Pentra C200 User Manual PDF

Clinical Chemistry Analyzer
User Manual
Ref: RAB274BEN
User Manual
User Manual
Ref: RAB274BEN
Contents
Foreword..........................................................................................................................................5
1. Revisions....................................................................................................................................6
2. Legal Information....................................................................................................................7
Introduction...................................................................................................................................9
1. Warning and Precautions..................................................................................................10
2. Instrument Overview............................................................................................................14
3. Operational Conditions.......................................................................................................17
4. Labels and Connections.....................................................................................................21
5. Printer........................................................................................................................................25
Specifications.............................................................................................................................27
1. Technical Specifications....................................................................................................28
2. Physical Specifications.......................................................................................................31
3. Reagents Specifications....................................................................................................33
4. Analysis Specifications.......................................................................................................35
5. Limitations...............................................................................................................................36
Software.........................................................................................................................................37
1. Software Overview...............................................................................................................38
2. Virtual Keyboard....................................................................................................................50
3. Software Functionalities....................................................................................................53
Quality Assurance...................................................................................................................55
1. Introduction.............................................................................................................................56
2. Graph from Control Results..............................................................................................57
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3. Details from Control Results............................................................................................60
4. Daily Statistics........................................................................................................................64
5. Cumulative Statistics...........................................................................................................68
Workflow........................................................................................................................................73
1. Workflow Overview..............................................................................................................74
2. Sample Materials...................................................................................................................76
3. Start of Day..............................................................................................................................77
4. Reagent Cassette Management.....................................................................................82
5. Calibration and Control......................................................................................................97
6. Patient Samples...................................................................................................................106
7. End of Day..............................................................................................................................125
Settings.........................................................................................................................................133
1. Managing Users Accounts..............................................................................................134
2. System Settings...................................................................................................................138
3. Patient and Sample Information Configuration......................................................147
4. Application Configuration................................................................................................155
Maintenance and Troubleshooting..........................................................................195

1. Maintenance..........................................................................................................................196
2. Troubleshooting...................................................................................................................252
Alarms............................................................................................................................................273
1. Alarm Overview....................................................................................................................274
2. To Save Alarms....................................................................................................................276
3. Alarm Code Principle.........................................................................................................277
4. System Alarms.....................................................................................................................278
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5. Sensor List.............................................................................................................................300
6. Error Flags.............................................................................................................................302
7. Error Code for ISE...............................................................................................................305
Description and Technology.........................................................................................307

1. Instrument Description.....................................................................................................308
2. Measurement Principle.....................................................................................................320
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iv User Manual
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Foreword
1. Revisions....................................................................................................................................6
2. Legal Information....................................................................................................................7
2.1. Declaration of Conformity...........................................................................................................7
2.2. Notice of Liability........................................................................................................................7
2.3. Document Symbols.....................................................................................................................7
2.4. Graphics......................................................................................................................................8
2.5. Trademarks.................................................................................................................................8
2.6. Copyright ® 2010 by HORIBA ABX SAS....................................................................................8
User Manual 5
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Foreword
Revisions
1. Revisions
Index Reference Software Version Date

A RAB274AEN 2550494104 September 2009
B RAB274BEN 1.06 (2550497106) January 2010
This document applies to the latest software version listed and higher versions.
When a subsequent software version changes the information in this document, a new electronic
issue (CD-ROM and/or online help) is released and supplied by HORIBA Medical.
To update a paper document, please contact your local HORIBA Medical representative.
6 User Manual
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Foreword
Legal Information
2. Legal Information
2.1. Declaration of Conformity
This instrument responds to the Standards and Directives named in the Declaration of Conformity.
Latest version of the EC Declaration of Conformity for this instrument is available on www.horiba.com.
2.2. Notice of Liability
The information in this manual is distributed on an "As Is" basis, without warranty. While every
precaution has been taken in the preparation of this manual, HORIBA Medical will not assume any
liability to any persons or entities with respect to loss or damage, caused or alleged to be caused
directly or indirectly by not following the instructions contained in this manual, or by using the
computer software and hardware products described herein in a manner inconsistent with our
product labelling.
2.3. Document Symbols
To alert the operator of potentially hazardous conditions, symbols described in this chapter are
provided wherever necessary throughout the manual.
Emphasizes information that must be followed to avoid hazard to either the operator or the
environment, or both.
Emphasizes information that must be followed to avoid possible damage to the instrument
or erroneous test results.
Emphasizes information that can be helpful to the operator before, during or after a
specific operational function.
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Foreword
Legal Information
Gives a summary of what can be achieved if the task is performed.
2.4. Graphics
All graphics including screens and printouts, photographs are for illustration purposes only and are
not contractual.
2.5. Trademarks
Microsoft and Windows are registered trademarks of Microsoft Corporation.

Other product names mentioned within this publication may be trademarks or registered trademarks
of their respective owners.
2.6. Copyright ® 2010 by HORIBA ABX SAS
All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written
permission of HORIBA Medical.
HORIBA ABX SAS

B.P. 7290
34184 MONTPELLIER Cedex 4 - FRANCE
Phone: +33 (0)4 67 14 15 16
Fax: +33 (0)4 67 14 15 17
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Introduction
1. Warning and Precautions..................................................................................................10

1.1. Limited Warranty.......................................................................................................................10
1.2. Safety Precautions....................................................................................................................11
1.3. Graphics and Symbols..............................................................................................................12
2. Instrument Overview............................................................................................................14
3. Operational Conditions.......................................................................................................17
3.1. Environment..............................................................................................................................17
3.2. Location....................................................................................................................................17
3.3. Grounding.................................................................................................................................18
3.4. Humidity and Temperature Conditions.....................................................................................18
3.5. Electromagnetic Environment Check........................................................................................18
3.6. Main Power Supply...................................................................................................................18
3.7. Environmental Protection..........................................................................................................19
3.8. Storage Conditions and Transportation....................................................................................19
3.9. Installation.................................................................................................................................19
4. Labels and Connections.....................................................................................................21

4.1. Serial Number Label..................................................................................................................21
4.2. Power Supply Connection........................................................................................................21
4.3. Fluidic System Connections.....................................................................................................22
4.4. Peripherals Connections...........................................................................................................23
4.5. Supplied USB Key....................................................................................................................23
4.6. Warnings, Cautions and Biological Risks Labels......................................................................23
5. Printer........................................................................................................................................25
User Manual 9
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Introduction
Warning and Precautions
1. Warning and Precautions
Work safety reliability and general characteristics are guaranteed by HORIBA Medical under the
following conditions:
■ User manual must be entirely read, and personnel trained by HORIBA Medical representative
before attempting to operate the instrument.
■ The user always operates with full knowledge and appreciation of instrument warnings and alarms.
■ Always refer to labelling and HORIBA Medical instructions in order to avoid to compromise system
integrity.
This instrument must be operated as instructed in the user manual. Any other use might compromise
system integrity and might be hazardous for the operator.
This instrument complies with Standards and Directives named in the Declaration of Conformity. The
latest version of the Declaration of Conformity for this instrument is available online at
www.horiba.com.
■ The reagents and accessories stipulated by HORIBA Medical have been validated in
accordance with the European Directive for in vitro medical devices (98/79/EC).
■ The use of any other reagents and accessories may place at risk the performance of
the instrument, engaging the user's responsibility. In this case, HORIBA Medical takes
no responsibility for the device nor for the results rendered.
■ Disposable gloves, eyes protection and lab coat must be worn by the operator.
■ Local or national regulations must be applied in all the operations.
■ Mobile phones should not be used in proximity of the instrument.
■ All peripheral devices should comply with relevant standards.
1.1. Limited Warranty
The duration of warranty is stipulated in the Sales conditions associated with the purchase of this
instrument. To validate the warranty, ensure the following is adhered to:
■ The system is operated under the instructions of this manual.
■ Only software or hardware specified by HORIBA Medical is installed on the instrument. This
software must be the original copyrighted version.
■ Services and repairs are provided by an authorized technician, using only approved spare parts.
■ The electrical supply of the laboratory adheres to national or international regulations.
■ The system is operated according to HORIBA Medical recommendations.
■ Specimens are collected and stored in normal conditions.
■ Reagents used are those specified in this user manual.
■ Proper tools are used when maintenance or troubleshooting operations are performed.
If this instrument has been supplied to you by anyone other than HORIBA Medical or an
authorized representative, HORIBA Medical cannot guarantee this product in terms of
specification, latest revision and latest documentation. Further information may be
obtained from your authorized representative.
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Introduction
1.2. Safety Precautions
1.2.1. Electronic and Moving Parts
The following parts must not be handled or checked by the user:

■ Electrical Power supply
■ Electronic circuit boards
Operator injury may occur from an electric shock. Electronic components can shock and
injure the user. Do not dismantle the instrument nor remove any components (covers,
doors, panels and so on) unless otherwise instructed within this document.
Danger of explosion if battery is not replaced correctly! When replacing the battery, always
use the same and/or equivalent type recommended by the manufacturer. Dispose of used
batteries according to the manufacturer's specific instructions.
Moving parts: It is strictly forbidden to disable sensors as it may cause operator injuries.
Protection covers must not be opened during instrument operations. Opening the doors
and covers during instrument operations causes the instrument emergency stop.
1.2.2. Biological Risk
Consider all specimens, reagents, calibrators, controls, etc. that contain human
specimen extracts as potentially infectious! Use established, good laboratory
working practices when handling specimens. Wear protective gear, gloves, lab
coats, safety glasses and/or face shields, and follow other biosafety practices as
specified in OSHA Blood borne Pathogens Rule (29 CFR part 1910. 1030) or
equivalent biosafety procedures.
All accessible surfaces of the instrument can be potentially contaminated by human

specimens. Disposable gloves and lab coat must be worn by the operator. Local and
national regulations must be applied in all the operations.
The manufacturer uses disinfectant product for instrument decontamination and highly recommends it
to decontaminate your instrument. See Maintenance and Troubleshooting > Maintenance > Other
Procedures > To Decontaminate the Instrument chapter to perform the instrument cleaning and
decontamination procedure.
See also:
■ To Decontaminate the Instrument, p.228
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Introduction
1.3. Graphics and Symbols
Switch off position Switch on position
Alternating current Manufacturer
In Vitro Diagnostic medical This product conforms to the EC Directives

device named in the Declaration of Conformity
Caution, consult
Biological risk
accompanying documents
Hot surface Up
Fragile, handle with care Handle with care
Do not stack Keep dry
Batch code Catalogue number
Use by Install before
Reagent Buffer
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Introduction
Calibrator Control
Content Single use only
This product should be disposed of and

recycled at the end of the useful life in
accordance with European Directive 2002/96/
Consult Instruction for Use
EC on Waste Electrical and Electronic
Equipment (WEEE) and/or European Directive
2006/66/EC on batteries and accumulators.
Notice of environment-
Packaging recycling mark
friendly use period
Risk of injury Risk of electric shock
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Introduction
Instrument Overview
2. Instrument Overview
The Pentra C200 includes several units:

■ A refrigerated sample and reagent container unit (1) which contains removable sample and reagent
trays. Sample tray holds 15 sample tubes or sample cups and reagent tray holds 15 reagent
cassettes. Temperature in the sample and reagent container unit is regulated at 8°C - 15°C
(46°F - 59°F). A barcode reader allows sample and reagent identification.
■ A cuvettes racks holder unit (2) with a 192 disposable cuvettes capacity.
■ An incubation reaction unit (3) regulated at 37°C ± 0.3°C (99°F ± 33°F) with a 24 cuvettes capacity.
■ A dust pod unit (4) for used cuvettes with a 216 used cuvettes capacity.
■ A cuvette loading unit (5) which enables transfer of new cuvettes from the cuvettes rack holder unit
(2) to the incubation reaction unit (3), and transfer of used cuvettes from the incubation reaction
unit (3) to the dust pod unit (4).
■ A probe unit (6) for reagent and sample pipetting and dispensing into cuvettes in the incubation
reaction unit (3) or into the ISE cup. The washing of the probe is performed in the probe wash
tower (7) and the DET.W bottle (8) on request.
■ A mixer unit (9) for reagent and sample mixing in the incubation reaction unit (3). The washing of
the mixer is performed between each use in the mixer wash tower (10) and the DET.W bottle (8) on
request.
■ Optional: ISE module (11) and ISE solution compartment (12).
■ A STAT unit (13) dedicated to emergency samples, which provides one tube holder for tube or
sample cup (with adapter). The STAT position is at room temperature and without barcode
identification.
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Introduction
Instrument Overview
1 = Sample and Reagent Container Unit (SRCU)
2 = Cuvettes rack holder unit (CM)
3 = Incubation Reaction Unit (IRU)
4 = Dust Pod unit (DP)
5 = Cuvette Loading Unit (CLU)
6 = Probe unit (PT)
7 = Probe wash tower
8 = DET.W bottle
9 = Mixer unit (MIX)
10 = Mixer wash tower
11 = Ion Selective Electrodes module (ISE)
12 = ISE solution compartment
13 = STAT unit
On the front panel, two LEDs and one button are available on the right of the screen. The two LEDs
display the status of the instrument: red and green when ready, red and green blinking when in
sleeping mode. An emergency stop button allows you to stop the instrument in emergency when
pressing for two seconds.
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Introduction
Instrument Overview
1 = Green LED
2 = Red LED
3 = Emergency stop button
16 User Manual
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Introduction
Operational Conditions
3. Operational Conditions
3.1. Environment
The operation of the Pentra C200 should be restricted to indoor location use only!
Instrument is operational at an altitude of maximum 2000 m (6562 ft).
The instrument is designed for safety from voltages surges according to INSTALLATION CATEGORY
II and POLLUTION DEGREE 2 (IEC 61010-1).
Please contact your local representative for information regarding operation locations, when it does
not comply with the recommended specifications.
3.2. Location
■ Place your instrument on a clean and leveled table or workbench.
Keep in mind that the instrument weighs approximately 95 kgs (209 lbs).
■ Avoid exposure to sunlight.

■ Place your instrument where it is not exposed to water or vapor.
■ Place your instrument where it is free from vibration or shock.
■ Place your instrument where an independent power receptacle can be used.
■ Use a receptacle different from the one used by a device that easily generates noise such as a
centrifuge, etc.
■ Provide a space of at least 15 cm (5.9 in) at the back of the instrument for a proper ventilation.
■ Make sure to provide enough space to open the main cover easily. The instrument height is
approximately 57 cm (22.5 in) closed cover and 100 cm (39.7 in) open cover.
The Power switch and Power supply connection should always be accessible! When
positioning the system for operational use, leave the required amount of space for easy
accessibility to these items.
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Introduction
3.3. Grounding
Proper grounding is required when installing the system. Check the wall outlet ground (earth) for
proper grounding to the facilities electrical ground. If you are unsure of the outlet grounding, contact
your facilities engineer to verify the proper outlet ground.
3.4. Humidity and Temperature Conditions
Instrument operating temperature: from +15°C (+59°F) to +30°C (+86°F), with a relative humidity of
45% - 85% maximum, without condensation. If the instrument is stored at a temperature lower than
10°C (50°F), it should stand for one hour at a normal room temperature before use.
Temperature gradient: 2°C (35°F) per hour.
3.5. Electromagnetic Environment Check
The instrument has been designed to produce less than the accepted level of electromagnetic
interference in order to operate in conformity with its destination, allowing the correct operation of
other instruments also in conformity with their destination.
In case of suspected electromagnetic noise, check that the instrument has not been placed in the
proximity of electromagnetic fields or short wave emissions, e.g. Radar, X-rays, Scanners, Cell
phones, etc.
3.6. Main Power Supply
Grounding is required. Check that earth wall-plug is correctly connected to the laboratory grounding
system. If there is no such system, a ground stake should be used.
Use only main supply cable delivered with the instrument.
Main power supply voltage fluctuations must not exceed +/- 10% of the nominal voltage.
Connections to supply have to be done by your local representative.
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Introduction
3.7. Environmental Protection
Used Accessories and Consumables Disposal

Disposable used accessories and consumables must be collected by a laboratory specialized in
elimination and recycling of this kind of material according to the local legislation.
Instrument Disposal
This product should be disposed of and recycled at the end of the useful life in
accordance with European Directive 2002/96/EC on Waste Electrical and Electronic
Equipment (WEEE) and/or European Directive 2006/66/EC on batteries and accumulators.
If any doubt, please contact your local representative.
3.8. Storage Conditions and Transportation
Instrument storage temperatures: from -10°C (+14°F) to +50°C (+122°F).
Prior to the shipping of an instrument by transporter, whatever the destination, an

external decontamination of the instrument must be carried out.
Before instrument removal from use, transportation or disposal, perform a general cleaning and a
draining of your instrument.
See also:
3.9. Installation
A representative will install your instrument and software.
Package content:
■ Pentra C200
■ Power supply cable
■ User Manual CD-ROM
■ Daily Guide
■ Waste tank
User Manual 19
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Introduction
■ Water tank
■ External tank sensor
■ Tubing
■ Fuses
■ Syringe tip insertion tool
■ Cuvette racks (x2)
■ Arm covers
■ Waste bags (x10)
■ Waste bag inserting tool
■ Rubber band
■ Cassettes 30/10 (x6)
■ Sticker labels for cassettes 30/10
■ USB key
■ Plastic pen for touch screen
■ Sample cup adapters (x5)
■ Hexagonal wrench (x2)
■ Screwdriver
■ Dummy electrode (with ISE module option)
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Introduction
Labels and Connections
4. Labels and Connections
4.1. Serial Number Label
The serial label is located at the back side of the instrument.
4.2. Power Supply Connection
The main power switch is located on the right-hand side of the instrument.
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Introduction
4.3. Fluidic System Connections
A color code is used for connections, tubing and tank identification. Blue color is used for distilled
water whereas red is used for waste.
1 = Liquid level sensor connector
2 = Water supply for sample pump unit, reagent pump unit and wash pump unit (PFA tube)
3 = Water supply for probe and mixer wash towers (silicon tube)
4 = ISE concentrated waste (silicon tube)
5 = Waste water (silicon tube)
■ PFA tube for water supply (2) needs to be tightened by hand without any tool.
■ Water tank needs to be kept at the instrument level and silicon tube (3) is cut to be as
short as possible between connector and tank.
■ Waste tank needs to be located below the instrument and loops must be avoided
between connector and tank. Cut the silicon waste water tube to avoid loops.
ISE concentrated waste can be separated from other non concentrated waste for special
disposal of contaminated liquid.
Dispose of waste according to your local/national guidelines for biohazard waste disposal.
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Introduction
4.4. Peripherals Connections
1 = Screen brightness adjustment
2 = Cable lock hook (PC and USB key)
3 = USB connections for external units (keyboard, printer,

mouse ...)
4 = Host connection
Whenever it is possible, leave USB port n°4 available for technical operations. If it is not
possible, use the USB port n°4 for mouse (option) or keyboard (option).
4.5. Supplied USB Key
The USB key is preloaded with the relevant data pertinent to the system.
4.6. Warnings, Cautions and Biological Risks Labels
Labels Warning Location
Risk of electric shock Power supply inlet
Covers of probe unit, mixer unit,

Do not touch moving parts
cuvette loading unit
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Introduction
Labels Warning Location
The tank contains hazardous material Waste tank
Contains hazardous materials (serum, Fluidic system connection, reaction

plasma or urine) tray cover
Risk of injury.
Halogen lamp cover, pump unit
Turn the power OFF before opening this
panel, ISE module panel
panel
Warning, hot surface.

Risk of personal injury due to hot
Detector unit
surfaces within the instrument. Wait for
the lamp to cool down before proceeding.
General warning, caution, risk of danger.
Risk of personal injury during the reagent
and sample container unit cover
Sample and reagent container unit,
operation (hands/fingers). Ensure that the
cuvette loading unit, reaction unit
unit cover closure is done cautiously.
Risk of personal injury during cuvette
loading unit operation (hands/ fingers).
Warning, biological hazard Dust pod
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Introduction
Printer
5. Printer
Use the printer supplied or approved by HORIBA Medical.
Latest printer compatibility information and consumable part numbers are available online
at www.horiba.com (Documentation Database: Other > instrument peripherals).
Printer installation has to be performed by an HORIBA Medical representative.
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Introduction
Printer
26 User Manual
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Specifications
1. Technical Specifications....................................................................................................28
1.1. Intended Use.............................................................................................................................28
1.2. Analysis Methods......................................................................................................................28
1.3. Throughput................................................................................................................................28
1.4. Reagent.....................................................................................................................................28
1.5. Sample......................................................................................................................................29
1.6. Calibrator and Control...............................................................................................................30
1.7. Measurement............................................................................................................................30
2. Physical Specifications.......................................................................................................31
2.1. Power Requirements.................................................................................................................31
2.2. Dimension and Weight..............................................................................................................31
2.3. Humidity and Temperature Conditions.....................................................................................31
2.4. Sound Level..............................................................................................................................31
2.5. Water Requirement...................................................................................................................32
2.6. Computer Characteristics.........................................................................................................32
3. Reagents Specifications....................................................................................................33
3.1. Reagent Notices........................................................................................................................33
3.2. Performance Data.....................................................................................................................34
3.3. Waste Handling Precautions.....................................................................................................34
4. Analysis Specifications.......................................................................................................35
5. Limitations...............................................................................................................................36
5.1. Maintenance..............................................................................................................................36
5.2. Interferences.............................................................................................................................36
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Specifications
Technical Specifications
1. Technical Specifications
1.1. Intended Use
The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidimetry and
potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on
homogeneous samples such as serum, plasma and urine.
1.2. Analysis Methods
The Pentra C200 system allows analysis by:

■ Colorimetry
■ Turbidimetry
■ Potentiometry (direct for serum and plasma, indirect for urine)
1.3. Throughput
■ 90 tests per hour without ISE

■ Up to 360 tests per hour with ISE
1.4. Reagent
Packaging accepted
■ Twin compartment cassette 30/10 from HORIBA Medical
■ Single compartment cassette 100 from HORIBA Medical
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Specifications
On board conditions
■ Capacity: 15 cassettes
■ Temperature: 8°C - 15°C (46°F - 59°F)
Reagent management
■ Barcode reagent identification
■ Back-up for same reagent
■ Remaining volume calculation
Reagent sampling
■ Same sampling probe for reagent and sample
■ Volume: 20 µL to 350 µL (1 µL increment)
■ Liquid level sensing
■ Shock detection
1.5. Sample
Sample types
■ Serum
■ Plasma
■ Urine
■ Homogeneous liquid
Sample tube types accepted

■ Primary tubes (length from 75 mm to 100 mm):
■ 5 and 7 mL (diameter: 13 mm)
■ 10 mL (diameter: 16 mm)
■ Sample cup (with adapter)
On board conditions
■ Capacity: 15 samples
■ Temperature: 8°C - 15°C (46°F - 59°F)
■ One STAT position at room temperature without barcode identification
Sample management
■ Barcode sample identification
■ Removable tray
■ STAT position
Sampling
■ Same sampling probe for sample and reagent
■ Volume: 2 µL - 45 µL (0.1 µL increment)
■ Automatic sample dilution (1/2 to 1/30,625)
■ Liquid level sensing
■ Shock detection
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Specifications
1.6. Calibrator and Control
Calibrator/Control positioning
Sample tray
Automatic standard dilution series

■ Dilution ratio with 1 cuvette: 1/2 - 1/175
■ Dilution ratio with 2 cuvettes: 1/175.1 - 1/30,625
1.7. Measurement
Reaction system
■ Reaction cuvettes: disposable resin cuvettes
■ Cuvette volume: 120 µL - 450 µL
■ Automatic loading and unloading of cuvettes
■ Holder cuvette capacity: 192 cuvettes
■ Waste cuvette capacity: 216 cuvettes
■ Mixing: stirring paddle
■ Reaction temperature: 37°C ± 0.3°C (99°F ± 33°F), air bath controlled
■ Measurement cycle: 20 seconds
■ Sampling cycle: 40 seconds
■ Reaction time: 20 seconds - 10 minutes
Optical system
■ Measurement principle: absorbance measurement (Bichromatic or Monochromatic)
■ Light source: tungsten-halogen lamp
■ Wavelength selection: filter wheel
■ Wavelengths: 340, 405, 510, 546, 570, 600, 660, 700 nm
Algorithms supported
■ Factor
■ Linear regression
■ Linear interpolation
■ LOGIT - LOG
■ Spline
■ Exponential
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Specifications
Physical Specifications
2. Physical Specifications
2.1. Power Requirements
■ Power supply: from 100 - 120 V to 200 - 240 V (+/- 10%), 50 Hz to 60 Hz

■ Maximum power consumption: 600 VA
■ Maximum heat output: 1,877 BTU/h (1,980 kJ/h)
Fuses characteristics:
Type Quantity Characteristics

Ceramic tube fuse 2 6.3 A / 250 V
2.2. Dimension and Weight
■ Instrument dimensions: 75.5 x 72.5 x 57 cm (Width x Depth x Height)

■ Instrument weight: 95 kgs (209 lbs)
2.3. Humidity and Temperature Conditions
Instrument operating temperature: from +15°C (+59°F) to +30°C (+86°F), with a relative humidity of
45% - 85% maximum, without condensation. If the instrument is stored at a temperature lower than
10°C (50°F), it should stand for one hour at a normal room temperature before use.
Temperature gradient: 2°C (35°F) per hour.
2.4. Sound Level
The maximum sound level is 65 dBa.
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Specifications
Physical Specifications
2.5. Water Requirement
■ De-ionized/distilled water
■ Water specifications:
■ Resistivity > 5 MOhms.cm
■ Conductivity < 0.2 µS/cm
2.6. Computer Characteristics
■ Color LCD touch screen: 10.4 inches

■ Industrial PC board: WindowsXP Embedded
■ Processor frequency: CPU 400 MHz
■ Memory capacity: 1 GB
■ RS232C, USB (4 ports)
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Specifications
Reagents Specifications
3. Reagents Specifications
In order for the instrument to operate correctly, high-quality reagents must be used.
HORIBA Medical provides a full range of reagents.
These reagents are used for in vitro diagnostic.
All these reagents are manufactured by:

HORIBA ABX SAS
B.P. 7290
34184 MONTPELLIER Cedex 4 - FRANCE
Phone: +33 (0)4 67 14 15 16
Fax: +33 (0)4 67 14 15 17
Refer to the reagent notices for Pentra C200 available on the Pentra C200 reagent online help (using
USB key) or online at www.horiba.com for all reagent specifications.
The reagents specified for this instrument have been approved in accordance with the
European Directive 98/79/EC (Annex III) for in vitro medical devices.
HORIBA Medical manufactures and markets reagents, calibrators and control bloods
specially designed for use with this analyzer. The use of products not recommended may
give erroneous results or instrument operation problems. For all information regarding the
recommended products, please contact your local representative.
3.1. Reagent Notices
Reagents, Controls and Calibrators notices/msds can be displayed on the Pentra C200
reagent online help (using USB key). Latest versions of these documents are available
online at www.horiba.com.
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Specifications
Reagents Specifications
3.2. Performance Data
For any information on reagent’s performance data such as Accuracy, Precision, Linearity,
etc., please refer to the reagent notices for Pentra C200 available on the Pentra C200
reagent online help (using USB key) or online at www.horiba.com.
3.3. Waste Handling Precautions
When disposing of waste, protective clothing must be worn (lab coat, gloves, eye
protection, etc.). Follow your local and/or national guidelines for biohazard waste disposal.
■ At the beginning of each day, before startup, check if the waste container needs to be
emptied.
■ During instrument operation, do not remove the liquid waste tube under any condition.
■ If required, waste can be neutralized before being discarded. Follow your laboratory's protocol
when neutralizing and disposing of waste.
■ Dispose of the waste container according to your local and/or national regulatory requirements.
34 User Manual
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Specifications
Analysis Specifications
4. Analysis Specifications
Items Specifications
Number of analysis methods Up to 240 methods (Common: 60, Serum: 60, Plasma: 60, Urine: 60)
Normal range 6 default types = 2 genders (male/female) x 3 age ranges (child/adult/
senior), others: 44 types
Multi-standard Up to 10 sets of multi-standard
Control sample Up to 40 controls registration
Profile Up to 20 profiles
Ratio calculation Up to 40 types of definition
Test selection Normal sample: Up to 15 samples
Emergency sample: 1 sample
Measurement results Measurement results: 10,000 tests
Raw data: 10,000 tests
Calibration results: 2,000 tests
Calibration curve Number of methods x 2 reagent lots (Old and New): 480 curves
QC measurement results Up to 10,000 tests
Number of identifiable patients (PID) Up to 7,000 patients
Number of maximum runs per day Up to 99 runs per day
User Manual 35
Ref: RAB274BEN
Specifications
Limitations
5. Limitations
5.1. Maintenance
Specific maintenance procedures are listed in the Maintenance and Troubleshooting Section. The
identified maintenance procedures are mandatory for proper use and operation of the Pentra C200.
Failure to execute any of these recommended procedures may result in poor reliability of
the system.
See also:
■ Maintenance, p.196
5.2. Interferences
The known interfering substances for each reagent are listed in the corresponding reagent notice
available on the Pentra C200 reagent online help (using USB key) or online at www.horiba.com.
36 User Manual
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Software
1. Software Overview...............................................................................................................38
1.1. Menu Structure.........................................................................................................................38
1.2. Generic Toolbar Description.....................................................................................................41
1.3. Menu Access Buttons Description............................................................................................42
1.4. Reagent Tray and Sample Tray Description.............................................................................43
1.5. Status Buttons Description.......................................................................................................45
1.6. Contextual Buttons Description................................................................................................48
2. Virtual Keyboard....................................................................................................................50
3. Software Functionalities....................................................................................................53
User Manual 37
Ref: RAB274BEN
Software
Software Overview
1. Software Overview
Pentra C200 includes a control station with a software installed on the embedded computer. The
touch screen allows to navigate easily in the application.
The main menu includes the following items:

■ (1) Generic toolbar (top of the screen) present in all windows.
■ (2) Menu access buttons (left and right-hand side) to enter in submenus.
■ (3) Reagent and sample trays (center of the screen).
■ (4) Instrument status buttons (bottom of the screen).
Either pressing on the screen or using the computer mouse (option) activates menu keys
and icons.
You can use either the virtual keyboard or computer keyboard (option) to type in information.
Keyboard Keys give a direct access to several functions and menus.
1.1. Menu Structure

All menus are displayed on the LCD touch screen and give access to the complete Pentra C200
functionalities except the Emergency Stop button located on the front of the instrument.
Generic toolbar structure
Start
Pause
STAT
Inventory Reagent Tray
MSDS Inventory
Audible Alarm Reagent List
Shutdown/Back Open cassette
Print Screen
Alarm
Help
Keyboard
38 User Manual
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Software
Software Overview
Main menu structure

Order Selection
Patient
Mask
Run Patient
Calibration
Results
Control
Login/Logout
Calibration Calibration
QC Setting
QC Registration
Reg Serial Dilut
Cal Regist
Services Logs
Application Configuration
Diagnostic
System Configuration
Customer Services
QC Graph
Details
Sample Status Legend
Daily
Reagent Status Legend
Cumulative
Cuvette
ISE Calibration
User Manual 39
Ref: RAB274BEN
Software
Software Overview
Services menu structure

Logs Operation Log
Application Configuration Applications Param 1
Param 2
ISE
Services Ratio SI
Profiles
Incompatibility Order
Wash Cycles
Diagnostic Seq2
Sensor
Adjust
DTR
System Configuration Setup
Host Connection
Printer
Audible Alarm
Password
Backup
Setup2
Define
Range
Reagent
Customer Services Sequence
Performance
WorkHour
Sleep Daily
Sleep Setting
Version
Menus displayed in grey are only available for engineers (EL).
40 User Manual
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Software
Software Overview
1.2. Generic Toolbar Description
The generic toolbar is always located at the top of the screen.
Generic toolbar buttons
Button Name Action Description
To run patient's sample, calibration Press for more than two seconds to
Start
or control. start.
The instrument stops sampling.

Measurement continues for samples
Pause To stop sampling.
or reagents already dispensed. If a
rerun is needed, it is not performed.
Allows to load and to register

STAT To run an emergency sample.
emergency sample in STAT position.
Opens Inventory menu for reagent

Inventory To register reagents.
registration and inventory.
Opens reagent notices and Material

Safety Data Sheets. A USB key with
MSDS To open the reagent online help.
reagent online files must be
connected to the instrument.
Allows to stop the audible alarm in

Audible Alarm To stop the sound alarm in progress.
progress.
Instrument status Indicates the instrument status.
Shutdown To open Shutdown window. Displayed only on the main screen.
Back To go to previous screen. Not displayed on the main screen.
Press for more than two seconds.

This function allows to print the
To print data / To send data to the
Print screen screen with a printer or to save it to a
host.
USB key. For saving, place a folder
named "UI" in the USB key.
Red when an alarm is triggered.
Orange when a warning is triggered.
Alarm To open Alarm screen.
Opens the Alarm screen displaying
error code, date and description.
Pentra C200 User manual. A USB

Help To open the Pentra C200 online help. key with the file must be connected
to the instrument.
Virtual keyboard with full

Keyboard To display Virtual Keyboard screen.
functionalities.
User Manual 41
Ref: RAB274BEN
Software
Software Overview
Key buttons
Key Action
F1 Start: to run patient's sample, calibration or control.
F2 Pause: to stop sampling.
F3 STAT: to run an emergency sample.
F4 Alarm: to open Alarm screen.
F7 Print screen: to print data / to send data to the host.
F8 Main screen: to go to the main screen.
F9 Keyboard: to display Virtual Keyboard screen.
Instrument status
Status Name Description
"START UP" The instrument initializes.
"READY" Instrument is ready to use.
"WAITING" status is displayed when:
"WAITING" ■ Waiting for emergency sample loading when an

emergency sample is ordered,
■ Pause is ordered.
"ANALYSING" Instrument performs analyses.
"STOPPED" System alarm or instrument stopped by the user.
1.3. Menu Access Buttons Description
Menu access buttons are located on both sides of the main screen. These buttons allow you to
access the main functions of the system.
Access buttons
Button Name Action
To open Order menu and to register patient, control and calibration tests
Order
as well as ISE sequence orders.
Run To open Run menu and to display results from the run in progress.
42 User Manual
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Software
Software Overview
Button Name Action
Results To open Results menu.
Calibration To open Calibration menu.
Services To open Services menu.
QC To open Quality Control menu.
1.4. Reagent Tray and Sample Tray Description
Reagent and sample trays are symbolized in the middle of the main screen. They allow you to
visualize solutions and samples configured and to give access to their details.
Reagent and sample status legend (color code) can be displayed by pressing specific areas on the
screen:
1 = Reagent status legend areas
2 = Sample status legend area
1.4.1. Reagent Tray Description
Reagent tray can hold 15 cassettes of two kinds:

■ One compartment cassettes which are used for reagents, diluents and wash solutions,
■ Two compartment cassettes for reagents and open cassettes.
Both kinds of cassettes are symbolized as two compartments cassettes.
Reagent status
Each reagent status is indicated by a color which legend is available by pressing the blue background
outside reagent tray representation.
User Manual 43
Ref: RAB274BEN
Software
Software Overview
Status color Legend Description
Empty No cassette registered on that position. Available position.
OK Cassette available for analysis.
The cassette needs to be checked because of one of the following

reasons:
To Be Checked ■ Reagent validity expiration
■ Reagent stability expiration
■ Reagent quantity not specified
Low volume:
Low Volume ■ Check the remaining number of tests,

■ If necessary change the cassette,
■ For open cassette, refill the cassette.
Reagent information
Reagent information details are available by pressing a cassette's opening on the reagent tray.
Legend Description
Pos Cassette position on reagent tray.
SeqNo Cassette number.
Name Reagent name.
Type Type of solution (R1, R2, Wash, Dil).
Vol Available volume for analysis in the concerned compartment.
Size Cassette size.
Tests Amount of tests that can be performed with the solution volume remaining in that cassette
compartment.
Total Amount of tests that can be performed with solutions available on the tray for the method
chosen.
Method Method name.
Lot Reagent lot number.
Expir. Validity date of the reagent.
Stability On board stability for reagent once cassette is open (in days).
Barcode Cassette barcode number.
1.4.2. Sample Tray Description
Sample tray can hold 15 samples which are symbolized by circles in between reagent tray cassettes.
The representation allows to check each sample positioning on sample tray, sample and patient
details and its measurement status.
To display sample and patient details, press on the circle corresponding to the sample. A pop-up
displays the sample position, the SID, the PID, the patient last name, first name, middle name and the
sample category.
Sample status
Each sample status is indicated by a color which legend is available by pressing the center of the
sample tray representation.
No order Sample detected but no sample registered on that position.
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Software
Software Overview
Empty No sample, available position.
Control Control sample registered.
Calibrator Calibrator sample registered.
Sample measurement in progress or pending (except for control and

In Progress
calibrator).
Available Measurement complete and validated.
Process Complete Measurement complete with result out of normal range.
For verification Measurement complete with error. Must be checked.
1.5. Status Buttons Description
Instrument status buttons are located at the bottom of the main screen. They give information about:
■ Cuvette status
■ The measurement starting and finishing time
■ STAT sample status
■ User
■ ISE calibration
1.5.1. Cuvette Status
The Cuvette button opens the Remaining Cuvettes screen that allows you to check or
to modify the amount of available cuvettes for measurement and the amount of
acceptable used cuvettes in the dust pod.
User Manual 45
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Software
Software Overview
1 = Cuvette
waste counter
2 = Back side
cuvette rack
3 = Front side
cuvette rack
The Remaining Cuvettes screen displays:

■ The amount of acceptable used cuvettes in the dust pod (cuvette waste counter) and allows you
to reset this amount to 216 when the used cuvettes are discarded.
■ When the dust pod is removed, the cuvette waste counter displays 0 (zero).
■ When the dust pod is emptied and put back, the cuvette waste counter is
automatically reset to 216.
■ The amount of available cuvettes in the back side cuvette rack and the front side cuvette rack.
Available cuvettes are symbolized as blue square and a cuvette counter displays the amount of
cuvettes in each rack.
When a new cuvette rack is installed, the -->96 button allows to specify it as a full cuvette rack (96
cuvettes).
If cuvettes are removed, you can specify remaining cuvettes by pressing the last square that
symbolizes cuvettes.
If a cuvette rack is removed or manually emptied, all cuvettes are cleared by pressing -->0 button.
■ If a cuvette rack is changed, the cuvette counter is automatically reset to full

cuvette rack.
■ If a cuvette rack is removed, the cuvette counter is automatically reset to empty
cuvette rack.
Do not wash and re-use cuvettes. They are designed for single use only.
See also:
■ Cuvettes Management, p.315
■ To Check Cuvettes, p.79
■ To Check Dust Pod, p.80
46 User Manual
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Software
Software Overview
1.5.2. ISE Calibration Status
The ISE Calibration button opens the Result of ISE Calibration screen that allows you
to check the latest ISE calibration result.
Result of ISE Calibration screen
1 = Last
calibration
results area
2 = Voltage
area
Two areas provide complete ISE calibration data:

1. Last calibration results area displays the date and time of the last calibration and the last
calibration results for Na+, K+ and Cl-.
Acceptable range for each ion is displayed between brackets. When calibration results are out of
range a "H" or "L" flag is added.
In case of problem on one of the electrodes during calibration, the calibration result is in red and
the error code is displayed. Error code description is available in the Alarms chapter of the user
manual. See Alarms > Error Code for ISE chapter.
2. Voltage area displays calibration voltage for Standard 1 (L) and Standard 2 (H).
The expected values of the slope and the sensitivity (difference between the low and high standard
values) for each electrode are given in the following table:
Electrode Slope normal range (mV/dec) Sensitivity normal range (mV)

Chloride 28 - 53 5.0 - 9.4
Potassium 37 - 67 9.0 - 16.3
Sodium 38 - 65 8.5 - 14.4
See also:
■ ISE Calibration Problems, p.267
■ Error Code for ISE, p.305
■ To Check ISE Calibration Validity, p.98
User Manual 47
Ref: RAB274BEN
Software
Software Overview
1.5.3. STAT Sample Status
The STAT sample status displays the sample status for the emergency
position in the STAT unit on the left-hand side of the instrument.
The sample status legend corresponding to the STAT position is the same as the status legend
displayed for normal samples. It is available by pressing the center of the sample tray representation.
See also:
■ Sample, p.310
■ To Run Emergency Sample, p.115
1.5.4. Timing
The measurement start and finish time is displayed during analysis.

Finish time may change during the run if samples are automatically
rerun.
Finish time is an estimation and the exact finish time may slightly
vary from the one estimated by the instrument.
1.5.5. User Status
User level is displayed at the bottom of the main screen. It allows to check
the level of the user logged on the instrument.
Three levels are available:

■ L1 user which is for the lab assistant in charge of the analysis.
■ L2 user which is for the system administrator.
■ EL user which is for the HORIBA Medical engineer.
1.6. Contextual Buttons Description
Contextual buttons are displayed at the bottom of most windows.
Button Name Action
Save To save the edited data.
Cancel To cancel an action.
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Software
Software Overview
Button Name Action
Delete To delete data.
Delete All To delete all data.
Print To print displayed data. Press more than one second.
Previous Page To display the previous page.
Next Page To display the next page.
Directory or partial keyboard To specify target directory.
When buttons are enabled they appear as in the table above. When disabled, buttons are dimmed.
User Manual 49
Ref: RAB274BEN
Software
Virtual Keyboard
2. Virtual Keyboard
A virtual keyboard is included in the application. It has the same functionalities as an external
computer keyboard.
You can access the virtual keyboard by pressing the Keyboard button from the generic toolbar at the
top of each screen. The keyboard displayed is a standard keyboard with full functionalities.
Press this button for keyboards access.
Standard keyboard with full functionalities
The keyboard may be moved to any position through the window. To move it, press and drag the On-
Screen Keyboard bar.
Other keyboards with partial functionalities can be displayed from several screens. Partial keyboards
functionalities corresponds to the field requirement and are of three types:
■ Limited alphanumeric keyboard
■ Numeric keyboard
■ Numeric keyboard for date and time settings
Press this button for partial keyboards access.
Limited alphanumeric keyboard
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Software
Virtual Keyboard
Button Action
Previous Page To display the previous page.
Next Page To display the next page.
OK To confirm input field entries and to close window.
Cancel To close keyboard window without saving entries.
<< or >> To display other characters in upper case, lower case, numbers and symbols.
BS To delete previous character.
Numeric keyboard
Button Action
Close To close keyboard window without saving entries.
AC To clear all entries in the input field.
Cancel To clear entries and to get original data back.
User Manual 51
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Software
Virtual Keyboard
Numeric keyboard for date and time settings
1 = Month
2 = Day
3 = Year
1 = Hours
2 = Minutes
3 = Seconds
Button Action
Next To jump to the next field.
Cancel To clear entries and to get original data back.
Close To close keyboard window without saving entries.
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Software
Software Functionalities
3. Software Functionalities
Icons
Icons are not always effective, depending on the screen currently displayed and instrument status.
Tooltips
A tooltip is a short piece of information about an icon or an area. Place your mouse pointer over a key
to display a tooltip.
Dropdown lists
A drop-down list is a list of predefined items. Select one item from the list to select it. Only one item
can be selected from the list.
Check boxes
Check boxes are options you can select. Click the check box to select the option. Several options can
be selected in a list of check boxes.
Radio buttons
Radio buttons are options you can select. Click the radio button to select the option. Only one option
can be selected in a list of radio buttons.
Data fields
Data fields can have a predefined format, like a date field, or can be empty. Use the keyboard to enter
data.
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Software
Software Functionalities
Scroll bars
Scroll bars can be either vertical or horizontal. Use it to display hidden parts of the screen or a list.
Calendars
Calendars help you to select a date. To choose a month, use the left and right arrows. Then choose
the day. When done, click randomly outside the calendar to close it.
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Quality Assurance
1. Introduction.............................................................................................................................56
2. Graph from Control Results..............................................................................................57

2.1. To Check Graph from Control Results......................................................................................57
2.2. Graph Interpretation..................................................................................................................58
3. Details from Control Results............................................................................................60

3.1. To Check Details from Control Results.....................................................................................60
3.2. Detailed List Interpretation........................................................................................................62
4. Daily Statistics........................................................................................................................64
4.1. To Check Daily Statistics..........................................................................................................64
4.2. Daily Statistics List Interpretation.............................................................................................66
5. Cumulative Statistics...........................................................................................................68
5.1. To Check Cumulative Statistics................................................................................................68
5.2. Cumulative Statistics List Interpretation...................................................................................70
User Manual 55
Ref: RAB274BEN
Quality Assurance
Introduction
1. Introduction
The Quality Control menu allows you to check the quality of measurements performed by the
instrument.
Statistical analyses of the control results are performed. These statistical analyses consist in
calculating the average, the standard deviation and the coefficient of variation of the measurement
over a defined period.
Controls for each method are stored for six months in the database and can be displayed as graph or
list. Statistical data is available for daily results or cumulative results.
To access the Quality Control menu press the Quality Control icon from the main screen.
The Quality Control menu is divided in four tabs:

■ Graph
■ Details
■ Daily
■ Cumulative
56 User Manual
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Quality Assurance
Graph from Control Results
2. Graph from Control Results
2.1. To Check Graph from Control Results
Follow this procedure to check results from a control on a graph.
Access: Main menu > QC > Graph (tab)
The Graph tab displays control results for a specific method on a graph. Results for a specific day or
over a 30 days period can be displayed. Two controls can be displayed simultaneously for a selected
method.
1. Select the method to analyze.

The method name is automatically displayed. Control names are automatically displayed for the
two graphs.
2. Select the sample category (Common, Serum, Plasma or Urine) from the Sample dropdown list.
3. Select the period range (Daily, Cumulative) from the Display Type dropdown list.
■ Daily: displays the results over the day for the date specified on the Date field.
■ Cumulative: displays the results corresponding to the last 30 days before the specified date on
the Date field.
4. Type the date or select the date from the calendar.

5. Select the control you want to display on the two graphs from the two Control Name dropdown lists.
Controls displayed in the dropdown lists are the controls specified for the selected method.
Controls are specified in the QC Settings screen ( Main menu > Calibration > QC Settings (tab) ).
6. Press Search to display the results for the selected controls.
Results corresponding to each control are displayed on the graphs.
For detailed information concerning graph interpretation, please refer to Quality Assurance
> Graph from Control Results > Graph Interpretation chapter.
User Manual 57
Ref: RAB274BEN
Quality Assurance
See also:
■ To Define Control Parameters for a Method, p.191
■ To Check Cumulative Statistics, p.68
■ To Check Daily Statistics, p.64
■ To Check Details from Control Results, p.60
■ Graph Interpretation, p.58
2.2. Graph Interpretation
The Graph tab displays control results for a specific method on a graph.
Access: Main menu > QC > Graph (tab)
For detailed information concerning the procedure to display the results, please refer to
Quality Assurance > Graph from Control Results > To Check Graph from Control Results
chapter.
For cumulative search, the X-axis displays days and months. The left side of Y-axis displays the
standard deviation (SD) and the right side the concentration.
1 = Search
parameters
2 = Standard
deviation
3 = Concentration
4 = Status legend
5 = Statistical data
Graphical results are displayed in three colors:

■ Black for results which are not flagged with an error or a warning.
■ Yellow for results which are flagged with a warning.
■ Red for results which are flagged with an error.
Error and warning flags depend on the rules specified for the method ( Main menu > Calibration >
QC Settings (tab) ).
Statistical data is available for each control.
■ N: Number of tests
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Quality Assurance
■ X: Mean calculated from the tests displayed

■ SD: Standard deviation calculated from the tests displayed
■ CV: Coefficient of variation calculated from the tests displayed
Any results flagged with an error are removed from the calculations.
The mean in the middle of the graph scale (straight line) can have two different values depending on
the calculation options chosen in the calibration screen ( Main menu > Calibration > QC Settings
(tab) ):
■ If the mode is set to Mean-R, the mean is the one registered with the control.
■ If the mode is set to X-R, the mean is calculated according to the results.
Mean-R
X-R
See also:
■ To Check Graph from Control Results, p.57
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Quality Assurance
Details from Control Results
3. Details from Control Results
3.1. To Check Details from Control Results
Follow this procedure to check detailed results from a control and to print them or to save
them.
Access: Main menu > QC > Details (tab)
1 = Date
management area
2 = Detailed results
list
1. Select the methods to analyze:

■ To select a specific method, type the method number or select it from the Method dropdown
list.
■ To select all methods, leave the Method field blank.
If a specific method is selected, the method name and the control name list are automatically
updated.
3. Select the output destination:
■ Monitor to display the results on the screen.
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Quality Assurance
■ Print to print the results if a printer is connected to the instrument (option).

■ File to save results to a USB key in .CSV format (spreadsheet program compatible). The
directory must be specified.
4. If File is selected from the Result Output dropdown list, choose a directory to save the results.
Press the directory button and select a folder from the USB key.
5. Select the control to be displayed from the Control Name dropdown list.
Controls displayed in the dropdown list are the controls specified for the selected method.
6. Select the period or the date to display in the Date management area:
■ To display control results from the last six months check Disable for the start date (From) and
for the end date (To).
■ To select a determined period, select the start date (From) and the end date (To). Type the date
or select the date from the calendar. The run number can be selected for the start date and the
end date. To display all runs, type "*" in the Run# field.
■ To select a period from a determined start date to the current date, select the start date (From)
and the run number. Check the Disable check box for the end date (To).
■ To select a period before a determined end date, select the end date (To) and the run number.
Check the Disable check box for the start date (From).
■ To select a specific day, enter the same date for the start date (From) and the end date (To).
7. Press Search to get the specified search results on the screen (Monitor), to print them (Print) or to
save them (File) according to the output format selected.
If more than 1000 items are available for the specified search, a pop-up is displayed:
"Too many results meet search condition. Narrow the condition and try again." Press
OK and narrow the search specifications.
Print format
8. To delete selected results from the database, press Delete. A pop-up is displayed and allows you
to confirm or cancel the deletion. Press OK to confirm or Cancel to cancel the ordered deletion.
Only level 2 users (L2) are allowed to delete control results.
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Results are displayed as a detailed list.
For detailed information concerning detailed list interpretation, please refer to Quality
Assurance > Details from Control Results > Detailed List Interpretation chapter.
See also:
■ Detailed List Interpretation, p.62
3.2. Detailed List Interpretation
The Details tab displays detailed results from a control in a list. Control results are associated with
potential warning and error descriptions.
Access: Main menu > QC > Details (tab)
Quality Assurance > Details from Control Results > To Check Details from Control Results
chapter.
Columns are described in the following table:
Heading Description
Date Date of the measurement (mm/dd/yyyy).
R# Run number.
No. Number to discriminate replicates for the same run.
Method Measurement method name.
CtrlID Control name.
Conc Control's concentration.
Invalid results are displayed as "****".
The unit and the digit of the decimal point are specified in Services > Application Configuration
> Applications > Param 1 (tab) .
WARN Displays the warning code for results flagged with a warning. Warning's code is determined
according to the rules specified in QC Settings ( Main menu > Calibration > QC Settings (tab) ).
The highest priority code is displayed if more than one warning is found.
ERROR Displays the error code for results flagged with an error. Error's code is determined according to
the rules specified in QC Settings ( Main menu > Calibration > QC Settings (tab) ). The highest
priority code is displayed if more than one error is found.
Only warning and error related to the standard deviation are displayed. Refer to the
Results screen to check for the occurence of error flags.
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Error and warning codes description
Code Description
1:2S Current result exceeds 2SD.
2:2S The two last results exceed 2SD.
2/3:2S Two out of the three last results exceed 2SD.
R:4S The difference between the two last results exceeds 4SD.
3:1S The three last results exceed 1 SD within the term.
4:1S The four last results exceed 1 SD within the term.
10:X[+] The 10 last results are greater than the mean.
10:X[-] The 10 last results are smaller than the mean.
7:X[+] The last results are likely to increase in seven consecutive points.
7:X[-] The last results are likely to decrease in seven consecutive points.
See also:
User Manual 63
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Quality Assurance
Daily Statistics
4. Daily Statistics
4.1. To Check Daily Statistics
Follow this procedure to check daily statistics from a control and to print them or to save
them.
Access: Main menu > QC > Daily (tab)

list.
updated.
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Daily Statistics
4. If File is selected from Result Output dropdown list, choose a directory to save the results. Press
the directory button and select a folder from the USB key.
6. Type the date or select the date from the calendar.

7. Select the run number. To display all runs, type "*" in the Run# field.
8. Press Search to get the specified search results on the screen (Monitor), to print them (Print) or to
Print format
Statistical results are displayed as a list.
For detailed information concerning daily statistics list interpretation, please refer to
Quality Assurance > Daily Statistics > Daily Statistics List Interpretation chapter.
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Daily Statistics
See also:
■ Daily Statistics List Interpretation, p.66
4.2. Daily Statistics List Interpretation
The Daily tab displays daily statistics from a control in a list. Control results are associated with
potential warning and error descriptions.
Access: Main menu > QC > Daily (tab)
For detailed information concerning the procedure to display the results, refer to Quality
Assurance > Daily Statistics > To Check Daily Statistics chapter.
Heading Description
N Number of valid data. Results with error are not included.
Mean(X) Average concentration calculated from valid data. Results with error are not included.
-2SD Calculated from the standard deviation obtained with valid data. Determine the lower value of the
confidence range. The value is blank when less than one point is available for calculation.
+2SD Calculated from the standard deviation obtained with valid data. Determine the higher value of the
SD Standard deviation calculated from valid data. Results with error are not included. The value is
blank when less than one point is available for calculation.
CV Coefficient of variation calculated from valid data. Results with error are not included. The value is
The digit of the decimal point is specified in Services > Application Configuration >
Applications > Param 1 (tab) .
Min Lower result. Results with error are not included.
Max Higher result. Results with error are not included.
Warning/Error Displays the higher error or warning code for results obtained during the day or the run. Error
code is determined according to the rules specified in QC Settings ( Main menu > Calibration >
QC Settings (tab) ). The highest priority code is displayed if more than one error is found.
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Daily Statistics
Code Description
See also:
User Manual 67
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Quality Assurance
Cumulative Statistics
5. Cumulative Statistics
5.1. To Check Cumulative Statistics
Follow this procedure to check cumulative statistics from a control and to print them or to
save them.
Access: Main menu > QC > Cumulative (tab)
1 = Date
management area
2 = Statistical
results list

list.
updated.
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4. If File is selected from Result Output dropdown list, choose a directory to save the results. Press
the directory button and select a folder from the USB key.
6. Select the period or the date to display in the Date management area:
■ To display control results from the last six months check Disable for the start date (From) and
for the end date (To).
■ To select a determined period, select the start date (From) and the end date (To). Type the date
or select the date from the calendar.
■ To select a period from a determined start date to the current date, select the start date (From).
Check the Disable check box for the end date (To).
■ To select a period before a determined end date, select the end date (To). Check the Disable
check box for the start date (From).
■ To select a specific day, enter the same date for the start date (From) and the end date (To).
7. Press search to get the specified search results on the screen (Monitor), to print them (Print) or to
Print format
Statistical results are displayed as a list.
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For detailed information concerning cumulative statistics list interpretation, please refer to
Quality Assurance > Cumulative Statistics > Cumulative Statistics List Interpretation chapter.
See also:
■ Cumulative Statistics List Interpretation, p.70
5.2. Cumulative Statistics List Interpretation
The Cumulative tab displays cumulative statistics from a control in a list. Control results are
associated with potential warning and error descriptions.
Access: Main menu > QC > Cumulative (tab)
Quality Assurance > Cumulative Statistics > To Check Cumulative Statistics chapter.
Heading Description
N Number of valid data. Results with error are not included.
Mean(X) Average concentration calculated from valid data. Results with error are not included.
-2SD Calculated from the standard deviation obtained with valid data. Determine the lower value of the
+2SD Calculated from the standard deviation obtained with valid data. Determine the higher value of the
SD Standard deviation calculated from valid data. Results with error are not included. The value is
CV Coefficient of variation calculated from valid data. Results with error are not included. The value is
The digit of the decimal point is specified in Services > Application Configuration >
Applications > Param 1 (tab) .
Min Lower result. Results with error are not included.
Max Higher result. Results with error are not included.
Warning/Error Displays the higher error or warning code for results obtained during the day or the run. Error
code is determined according to the rules specified in QC Settings ( Main menu > Calibration >
QC Settings (tab) ). The highest priority code is displayed if more than one error is found.
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Code Description
See also:
User Manual 71
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Workflow
1. Workflow Overview..............................................................................................................74
2. Sample Materials...................................................................................................................76
3. Start of Day..............................................................................................................................77
3.1. To Log on the Instrument..........................................................................................................77
3.2. To Check Cuvettes...................................................................................................................79
3.3. To Check Dust Pod...................................................................................................................80
3.4. To Check USB Key (Option)......................................................................................................81
3.5. To Switch On the Printer (Option).............................................................................................81
4. Reagent Cassette Management.....................................................................................82

4.1. Reagent Availability...................................................................................................................82
4.2. To Load Cassettes....................................................................................................................86
4.3. Cassette Registration................................................................................................................89
4.4. To Delete a Cassette.................................................................................................................93
4.5. To Register an Open Cassette..................................................................................................94
5. Calibration and Control......................................................................................................97

5.1. To Calibrate ISE........................................................................................................................97
5.2. Check of Calibration and Control Status..................................................................................98
5.3. To Order Calibration and Control............................................................................................100
5.4. Check of Calibration and Control Results...............................................................................103
6. Patient Samples...................................................................................................................106
6.1. To Order Patient Samples.......................................................................................................106
6.2. To Run Emergency Sample....................................................................................................115
6.3. To Check Results....................................................................................................................117
7. End of Day..............................................................................................................................125
7.1. To Empty the Worklist.............................................................................................................125
7.2. To Clean ISE with Etching (Option).........................................................................................126
7.3. To Check System Solutions....................................................................................................127
7.4. To Clean Sample and Reagent Container Unit.......................................................................128
7.5. To Clean the Probe with Deproteinizer...................................................................................128
7.6. Sleeping Mode........................................................................................................................129
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Workflow Overview
1. Workflow Overview
The sleeping mode must be used for a daily use of the instrument. If the instrument is switched off for
a prolonged period of time, special care must be followed for the instrument switching off and
switching on (see Maintenance and Troubleshooting > Maintenance > Other Procedures > To Perform
an Extended Shutdown with ISE, To Perform an Extended Shutdown without ISE, To Switch On an
Instrument with ISE After an Extended Shutdown and To Switch On an Instrument without ISE After an
Extended Shutdown chapters).
Follow this workflow for a daily use of the instrument.
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Workflow
Workflow Overview
Log in
Checks:
Instrument
- Cuvettes
- Dust pod
- USB key
- Printer (option)
Reagents inventory
Calibration validity
Perform ISE calibration (option)
Run calibration if necessary
Run control
Check results
Run patient samples
Check results
End of day
- ISE cleaning (option)
- Refill water tank
- Discard waste tank
See also:
■ To Perform an Extended Shutdown with ISE, p.233
■ To Switch On Instrument with ISE after an Extended Shutdown, p.235
■ To Perform an Extended Shutdown without ISE, p.234
■ To Switch On Instrument without ISE after an Extended Shutdown, p.237
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Sample Materials
2. Sample Materials
Samples such as serum, plasma, urine and homogeneous liquid are to be used on the Pentra C200.
Ensure that a sufficient sample volume without air bubble or foam is placed on the
instrument whatever the sample type (calibrator, control, patient sample).
Refer to each reagent notice to determine the sample volume required (see Performance on
Pentra C200 > Sample Volume paragraph) and take into account the following dead volumes:
■ primary tubes: 1 mL,
■ sample cups: 100 µL.
For any further information or special care regarding samples such as pretreatment or sample
stability, please refer to the corresponding reagent notice.
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Start of Day
3. Start of Day
At the beginning of a day of work, the instrument wakes from sleeping mode.
When the instrument is in sleeping mode, the green LED on the right of the screen blinks and the
screen is black. A few minutes before the automatic wake up of the instrument, a pop-up warns the
user that preparation is in process and gives the estimated completion time. During this process the
instrument is in "ANALYSING" status and performs several checks:
■ Mixer initialization,
■ Probe initialization,
■ Cuvette Loading Unit (CLU) initialization,
■ Probe cleaning if ordered for sleeping mode wake up ( Services > Customer Services > Sleep
(tab) ),
■ Halogen lamp stabilization.
When the preparation process is finished the status changes from "START UP" to "READY" and the
pop-up disappears.
Before starting measurements, several checks need to be performed to avoid shortage or overflow.
3.1. To Log on the Instrument
Follow this procedure to log on the instrument if several users are using the instrument.
Access: Main menu > Shutdown
When the instrument wakes from sleeping mode the last user is still logged in. To change user, the
logout procedure must be followed.
1. Press the Shutdown button in the generic toolbar at the top of the main screen.
A pop-up with several choices (Sleep, Power Off, Logout, Restart, Cancel) is displayed.
2. Press Logout.
A pop-up is displayed to confirm system logout.
3. Press OK to confirm system logout or Cancel to cancel the ordered logout.
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Start of Day
1 = User name dropdown list
2 = Password field
3 = Login button
4 = Logout button
4. Wait until the Login button is active and press the arrow from the users dropdown list to display
users.
5. Select the user.
6. Type your password in the password field.
7. Press Login.
A pop-up is displayed for user confirmation.
8. Press OK.
9. Press the Back button in the generic toolbar to enter the main screen.
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Start of Day
3.2. To Check Cuvettes
Follow this procedure to check that enough cuvettes are available on the instrument
before starting measurements.
Access: Main menu > Remaining Cuvettes
1. Press the Cuvette button on the main screen to open the Remaining Cuvettes screen.
2. Open the main cover.

3. Check the concordance between the racks of cuvettes and the Remaining Cuvettes screen.
4. If needed, replace the empty racks with full racks.
■ If a cuvette rack is changed, the cuvette counter is automatically reset to full

cuvette rack.
■ If a cuvette rack is removed, the cuvette counter is automatically reset to empty
cuvette rack.
■ Any dirt on the cuvette rack mount plate should be cleaned before adding a new rack.
■ Check that the cuvette racks are well-positioned. If not, the loading unit could
collide with the cuvette racks during measurement.
■ Do not wash and re-use the cuvettes. They are designed for single use only.
5. Check that the new rack is correctly configured on the Remaining Cuvettes screen.
6. If necessary, press -->96 on the cuvette counter for the concerned rack.
7. If the added cuvette rack is not full, specify the cuvettes number by pressing the last square that
symbolizes cuvettes.
See also:
■ Cuvette Status, p.45
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Start of Day
3.3. To Check Dust Pod
Follow this procedure to check the number of acceptable used cuvettes in the dust pod.
Access: Main menu > Remaining Cuvettes
1. Check the number of acceptable used cuvettes in the dust pod. The Remaining Cuvettes screen
displays the amount of acceptable used cuvettes in the dust pod (cuvette waste counter).
■ When the dust pod is removed, the cuvette waste counter displays 0 (zero).
■ When the dust pod is emptied and put back, the cuvette waste counter is
automatically reset to 216.
2. If necessary empty the dust pod.

a. Remove the dust pod.
b. Remove the lid and the plastic bag.
c. Discard the plastic bag containing used cuvettes.
Dispose of used cuvettes according to your local/national guidelines for biohazard

waste disposal.
d. Place a new plastic bag in the dust pod by following the procedure described in the
maintenance chapter. See Maintenance and Troubleshooting > Maintenance > Other
Procedures > To Replace Dust Bag chapter.
3. If the dust pod is emptied and put back, the cuvette waste counter should be automatically reset
to 216.
a. Check the Remaining Cuvettes screen ( Main menu > Remaining Cuvettes ).
b. If the cuvette waste counter is not reset to 216, press Reset in the Cuvette waste area.
Check that the dust pod lid is completely engaged (a click sound is heard). If not, it
could collide with the loading unit during measurement.
See also:
■ To Replace Dust Bag, p.225
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Start of Day
3.4. To Check USB Key (Option)
After every day of work, data can be automatically saved on USB key for backup. The USB Auto
Backup must be configured on ON in Services > System configuration > Backup (tab) .
Check that a USB key is connected on one of the USB port on the right-hand side of the instrument.
Whenever it is possible, leave USB port n°4 available for technical operations. If it is not
possible, use the USB port n°4 for mouse (option) or keyboard (option).
3.5. To Switch On the Printer (Option)
If a printer is connected to the instrument, follow this procedure before starting

measurements.
1. Check the printer paper.

2. If there is not enough paper, add more paper according to the printer user manual.
3. Press the On/Off switch to switch on the printer.
4. Check that the control LEDs are on.
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Reagent Cassette Management
4. Reagent Cassette Management
4.1. Reagent Availability
4.1.1. To Check Reagent Availability
Follow this procedure to check reagents, diluents and cleaners availability.
Access: Inventory > Inventory (tab)
The Inventory tab must be displayed.
The Inventory tab allows you to check reagent availability and volumes. Volumes are deduced from
the last use of reagent cassettes. The number of tests available is in accordance with the method
configured with the reagent. For new cassettes, theoretical values are displayed and actualized after
the first pipetting.
1. Open the Outer (R1) tab.

It displays information concerning reagents located on the outer position on the reagent tray.
■ Red background is displayed when the validity or the stability is out of date.
■ Orange background is displayed when reagent volume is low (less than 10%).
■ Green background is displayed when reagents are available for analysis.
2. Check that reagents needed for your tests are registered on one of the 15 positions on the tray.
If cassettes needed for tests are not registered, you can load and register new
cassettes by following the cassettes loading procedure and the cassettes registration
procedure (see Workflow > Reagent Cassette Management > To Load a Cassette
chapter and Workflow > Reagent Cassette Management > Cassette Registration > To
Register a Cassette chapter).
3. Check reagents for the tests you intend to run on the instrument.
Total displays the total number of tests that can be performed on the instrument with the reagents
registered on board.
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If an ISE module is installed (option), keep cassette position 15 for a 30/10 open
cassette (No 801, Name DIL1) containing distilled water (R1) and Standard 1 solution
(R2). Change distilled water and Standard 1 solution every week. Clean the cassette,
dry it and refill it every week.
4. Check the Inner (R2) tab.
If several cassettes of the same reagent are installed on the reagent tray, do not forget to
run a new calibration when a new cassette is used.
See also:
■ Inventory Screen, p.83
■ Reagent List Screen, p.85
■ To Load Cassettes, p.86
■ To Register a Cassette, p.89
4.1.2. Inventory Screen
The Inventory screen displays the list of cassettes on board and their information.
The Inventory screen displays three tabs on the right of the screen:
■ Inner: displays the inner compartment of the cassette (R2),
■ Outer: displays the outer compartment of the cassette (R1),
■ DET.W: displays information about the DET.W bottles.
Inner and Outer tabs

Inner and Outer tabs display the following information about each cassette compartment. Cassette's
information is sorted by position of cassettes on the reagent tray.
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Legend Description
Name Reagent name.
Type Type of solution.
Size Cassette size.
Vol(mL) Available volume for analysis in the concerned compartment. For a new cassette the
volume is the initial volume registered for the reagent (dead volume deducted). For used
cassettes, the volume is measured during each test and kept in memory.
Tests Number of tests that can be performed with the volume remaining in that cassette
compartment.
Method Method name.
Total Number of tests that can be performed with solutions available on the tray for the method
chosen.
Expir. Expiration date of the reagent (mm/dd/yyyy).
Stability On board stability of the reagent (in days).
DET.W tab
The DET.W tab displays information about the two DET.W bottles which are used for the mixer (MIX)
wash or for the probe (PB) wash.
Legend Description
Pos Bottle positions:
■ MIX: solution for mixer wash
■ Probe: solution for probe wash
Name Solution name.
Vol(mL) Available volume of wash solution in the DET.W bottle. This information is only available
for the probe wash solution. The volume is measured and updated at the beginning of
every run.
Tests Amount of tests that can be performed with the volume remaining in the DET.W bottle.
Expir. Expiration date of the wash solution (mm/dd/yyyy).
Stability On board stability of the wash solution (in days). By default the stability for the DET.W
solutions is 14 days.
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Legend Description
Wash# Number of available wash for the mixer. The number of washes is decreased after every
wash of the mixer. A warning is displayed at the beginning of the run when the number of
washes exceeds the number of washes specified.
A color code is associated with the cassette status:

■ Red: validity date expired or stability expired,
■ Orange: reagent low volume (less than 10%),
■ White: no reagent registered,
■ Green: reagent available for measurement.
See also:
■ Reagent List Screen, p.85
■ To Check Reagent Availability, p.82
4.1.3. Reagent List Screen
The ReagentList screen allows you to check all the methods that can be performed on the instrument
with the reagents available on board.
Access: Inventory > ReagentList (tab)
The reagent list displays two tabs:

■ R1&R2: displays the list of methods available on the instrument with the reagents on board.
■ Wash&Dil: displays the list of diluents and wash solutions on board.
R1&R2 tab
The reagents tab displays the list of reagents registered on board ordered by the method name which
make use of them. The position of R1 and R2 on the reagent tray is displayed as well as the number
of tests that can be performed for the method.
A Print button is available at the bottom of the screen. If a printer is connected (option), press more
than one second to print a table with complete method inventory as well as diluents and wash solutions.
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Wash&Dil tab
The Wash&Dil tab displays the list of diluents and wash solutions registered on board. The name and
the type of solution is displayed as well as the position on the reagent tray and the volume available.
See also:
■ To Check Reagent Availability, p.82
4.2. To Load Cassettes
Follow this procedure to load cassettes in the reagent tray.
If several cassettes of the same reagent are installed on the reagent tray, do not forget to
run a new calibration when a new cassette is used.

2. Remove the Sample and Reagent Container Unit (SRCU) cover.
3. Remove the reagent and sample trays from the SRCU.
4. Detach the sample tray by pulling it up.
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Reagent and sample tray removal from the SRCU Sample and reagent tray dismantling
5. Load the cassettes in any available position of the reagent tray.
Ideally, cassettes should be placed in positions which balance the tray.
6. Put back the reagent and sample trays in the SRCU by inserting the two guide pins in the two
bigger holes of the reagent tray.
Turn the tray slowly to make the guide pin fit.
7. Remove the caps from the cassettes.

8. Press on the center of the trays to make sure the trays are correctly placed.
9. If necessary, remove bubbles with a pasteur pipette.
10. Put back the SRCU cover in correct position.
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SRCU cover in correct position
11. Check that the probe has no obstacle on its way.

12. Close the main cover.
Do not forget to register the cassettes after their loading (see Workflow > Reagent
Cassette Management > Cassette Registration > To Register a Cassette chapter).
A barcode scan must be performed as soon as a cassette is installed on board, replaced,

moved or removed.
See also:
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4.3. Cassette Registration
4.3.1. Cassette Management Overview
Access: Inventory > Reagent Tray (tab)
1 = Reagent tray representation
2 = Cassette information area
The Reagent Tray tab displays the reagent tray representation and a cassette information area. Each
cassette is symbolized by two circles for outer compartment and inner compartment. To get
information about a cassette, press the concerned circle on the tray representation and information
about the cassette compartment is displayed in the cassette information area.
4.3.2. To Register a Cassette
Follow this procedure to register cassettes loaded on the reagent tray.
■ To proceed to cassette registration, reagents must already be registered on the instrument ( Main
menu > Services > System configuration > Reagent (tab) ),
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■ Reagents provided by HORIBA Medical are already registered on the instrument,

■ Only reagents for open channel must be registered by the user,
■ Only level 2 users (L2) are allowed to register new reagents.
■ Open cassettes must be registered on the instrument (see Workflow > Reagent Cassette
Management > To Register an Open Cassette chapter for open cassette registration),
■ Reagent cassettes must be loaded on the instrument.
1. Press Barcode Scan to register new cassettes.

The instrument checks the cassettes available on the instrument.
A barcode scan must be performed as soon as a cassette is installed on board,

replaced, moved or removed.
2. Press Save to save cassette registration.
If the instrument encounters a barcode scan problem for a cassette, follow the procedure
described in the troubleshooting chapter. See Maintenance and Troubleshooting >
Troubleshooting > Undetected Cassette chapter.
See also:
■ To Register Reagents, p.155
■ Reagent Tray Screen, p.90
■ Alarms on Cassettes, p.254
■ Undetected Cassette, p.253
■ Reagent, p.308
■ To Register an Open Cassette, p.94
4.3.3. Reagent Tray Screen
The Reagent Tray screen displays a representation of the reagent tray and the characteristics of each
cassette compartment.

moved or removed.
Reagent cassettes
The Reagent Tray screen displays the reagent tray representation. Cassettes are numbered from 1 to
15 corresponding to the cassette position on the reagent tray. Each circle corresponds to one of the
cassette compartments.
Each circle displays a color code associated with the cassette status:
■ Red: reagent shortage or validity date expired or stability expired,
■ Orange: reagent low volume (less than 10%),
■ White: no cassette registered,
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■ Green: cassette available for measurement,

■ Grey: single compartment cassette, the inner compartment does not exist and is displayed in grey.
Press a circle to display the compartment information in the information area.
Legend Description
Seq# Cassette number.
Name Reagent name.
Type Type of solution.
Vol Available volume for analysis in the concerned compartment. For a new cassette the
volume is the initial volume registered for the reagent (dead volume deducted). For used
cassettes, the volume is measured during each test and kept in memory.
Size Cassette size.
Tests Amount of tests that can be performed with the volume remaining in that cassette
compartment.
Total Amount of tests that can be performed with solutions available on the tray for the method
chosen.
Method Method name.
Expir. Expiration date of the reagent (mm/dd/yyyy).
Stability On board stability of the reagent (in days).
Barcode Cassette barcode number.
All information is automatically registered after performing a barcode scan or by typing the barcode in
the Barcode field. To enter a barcode manually, press the partial keyboard button and type the barcode.
DET.W bottles
The two DET.W bottles are displayed in the top right corner of the reagent tray representation. DET.W
information is displayed in a specific information area. To register a DET.W solution, press on the
circle corresponding to the probe DET.W bottle (Wash(PB)) or to the mixer DET.W bottle (Wash(MIX)).
Information area for probe's DET.W Information area for mixer's DET.W
In the information area, select the reagent to register in the DET.W bottle by pressing the Reagent
selection button.
Only reagent configured as DET.W enabled are available for reagent selection. Reagents
are configured in the Reagent screen ( Main menu > Services > System Configuration
> Reagent ).
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■ For probe's DET.W, the number of tests and the stability are automatically displayed. By pressing
Volume Reset after a change of the solution, the volume of the DET.W bottle is automatically set
to 18.2 mL. The volume is measured and updated at the beginning of every run.
■ For mixer's DET.W, the mixer is washed each time in the DET.W bottle. The number of washes
that can be performed in the bottle (363 max.) and the stability are automatically displayed. When
the solution is changed, press Number Reset to reset the number of washes allowed in the same
solution. The Wash# field is automatically reset to 363.
■ If the number of washes for the DET.W mixer exceeds the number of washes
specified, a pop-up is displayed at the beginning of the run to warn the user: "The use
of DET.W liquid for MIX exceeds the limits".
■ If no DET.W solution is configured for the mixer, a pop-up is displayed at the beginning
of each run.
Contextual buttons
Cassettes from the reagent tray can be managed through the contextual buttons at the bottom of the
screen.
Button Action
Save To save the action performed.
Cancel To cancel an ordered action.
Delete All To delete all the cassettes from the reagent tray.
Delete To delete a selected cassette from the reagent tray.
Volume Reset To reset the volume of a selected cassette. Available only for reagent code's higher than
600.
Barcode Scan To perform a barcode scan for the update of the cassettes available on the reagent tray.
Print If a printer is connected (option), press more than one second to print a table with
complete reagent inventory. The table displays all cassette information:
■ The compartment position,
■ The cassette name,
■ The solution type,
■ The reagent lot number,
■ The compartment size,
■ The volume of solution,
■ The number of tests that can be performed with the solution remaining in the
compartment,
■ The method name concerned by the reagent,
■ The number of tests that can be performed with solutions available on the tray for the
method,
■ The expiration date of the reagent,
■ The on board stability of the reagent (days),
■ The cassette barcode number.
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See also:
■ Reagent, p.308
■ To Delete a Cassette, p.93
4.4. To Delete a Cassette
Follow this procedure to delete the cassettes or the wash solutions (DET.W) registered.
The Reagent Tray tab must be displayed.
1. Select the cassette position by presssing the corresponding circle on the tray representation.
2. Check the identification of the selected cassette on the cassette identification area.
3. Press Delete.
4. Press Save to validate the deletion.
A pop-up is displayed and allows you to confirm or to cancel the deletion.
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All the cassettes registered on the tray can be deleted by pressing Delete All button.
See also:
4.5. To Register an Open Cassette
Follow this procedure to register an open cassette before it can be detected by the
instrument.
Access: Inventory > OpenCassette (tab)
To register an open cassette, reagents used in the cassette must be already registered on the
instrument ( Main menu > Services > System Configuration > Reagent (tab) ).
Only solutions registered as diluent (reagent code from 801 to 8XX) or registered for open
channels (from 901 to 905) can be used in open cassettes. The Code's Method Table
chapter allows to check the list of diluents registered on the instrument (see Settings >
Application Configuration > Code's Method Table chapter).
For example, the open cassette No 801 is used for the dilution of urine samples with Standard 1
solution for ISE tests and for the post-dilution with distilled water for rerun.
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In
In = R2: Standard 1 (811)
Out = R1: distilled water (810)
Out
1. Type 801 in the Open Cassette No field.

If the cassette number specified is already used, reagent code for both compartments is displayed.
2. Check the reagent codes for Standard 1 and distilled water in the Reagent screen ( Main menu >
Services > System Configuration > Reagent ).
3. Select the reagent code 811 corresponding to Standard 1 in the ReagentCode(In) field (R2).
4. Select the reagent code 810 corresponding to distilled water in the ReagentCode(Out) field (R1).
5. Press Save to save the open cassette registration.
Once an open cassette is registered, load the cassette on the instrument (see Workflow > Reagent
Cassette Management > To Load Cassettes chapter), then register the cassette (see Workflow >
Reagent Cassette Management > Cassette Registration > To Register a Cassette chapter).
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Open cassette must be identified with barcode stickers (Stickers for reagent cassettes
on Pentra C200 HAX0297B) provided by HORIBA Medical.
See also:
■ To Load Cassettes, p.86
■ Reagent, p.308
■ Code's Method Table, p.193
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Calibration and Control
5. Calibration and Control
Before running any sample, the user needs to check daily calibration and control validity for
the concerned tests.
5.1. To Calibrate ISE
5.1.1. To Order an ISE Calibration
Follow this procedure to calibrate ISE at the beginning of every day of work.
Access: Main menu > Order > Selection (tab)

3. Place Standard 2 solution (2 mL) for ISE calibration in a tube.
4. Load the tube at the first position on the sample tray.
5. Close the SRCU cover.
7. In Main menu > Order > Selection (tab) , register ISE calibration:
a. Select position 1.
b. Select ISE Calibration from the Type dropdown list.
c. Press Save.
8. In Main menu > Services > Customer Services > Sequence (tab) , press ISE Calibration
button.
The ISE calibration starts. When calibration is finished instrument status switches from
"ANALYSING" to "READY".
ISE calibration takes approximately seven minutes. Calibrations and controls for
colorimetric measurements can be registered during ISE calibration. Wait until the
status is "READY" to open the SRCU and load the tubes on the sample tray.
■ ISE calibration validity must be checked after each calibration.

■ This calibration is stable for eight hours.
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See also:
■ Sequence, p.244
5.1.2. To Check ISE Calibration Validity
Follow this procedure to check ISE calibration validity.
Access: Main menu > ISE Calibration
1. Press ISE Calibration button from the main screen.
2. Check the Error Code field.

■ If error code is 0000, the calibration is valid and the samples can be run. Remove the Standard
2 sample tube (position 1) and discard it according to your local/national guidelines for
biohazard waste disposal.
■ If error code is different than 0000, an error occured during the calibration. Check the Standard
2 sample tube position in the sample tray and rerun an ISE calibration. If the error persists,
refer to the troubleshooting chapter (see Maintenance and Troubleshooting > Troubleshooting).
See also:
■ ISE Calibration Status, p.47
5.2. Check of Calibration and Control Status
5.2.1. Test Color Code
All tests are displayed on the Selection screen. According to the sample category selected, they are
associated with a color code corresponding to the calibration and control status.
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1 = Worklist
2 = Sample details and orders
3 = Button to expand or collapse the list
If a cassette used for a test is not on board, the test is not displayed.
Color Status Action

Register the reagent and the cassette used for
No test The test is not displayed. the concerned test.
Turns to
Calibration is not valid or User needs to run a new calibration.
Red background:
required. Turns to when selected
User needs to run a new control.
Yellow background: Control error or required.
Turns to when selected
Select the Mask tab (in Main menu > Order )
The test is masked and will not
Grey Background: and unselect the mask for the concerned test.
be run.
Turns to
The test is available for
No background: measurements. Calibration and Turns to when selected
controls are valid.
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5.2.2. To Check Calibration and Control Validity
Follow this procedure to check, for colorimetric tests, calibration and control validity
before running samples.
1. If the worklist is not empty:

a. Press Delete All.
b. Press Save to validate the deletion.
2. Press the first position in the worklist to select position 1.

3. Check the tests available on the instrument and their status which is associated with a color code.
■ If several cassettes of the same reagent are installed on the reagent tray, do not
forget to run a new calibration when a new cassette is used.
■ Always run controls for a test before samples after each new calibration and at the
beginning of the work session.
■ If using ISE module (option), ISE calibration must be run at the beginning of every
day of work. This calibration is stable for eight hours.
5.3. To Order Calibration and Control
Follow the following procedures to run calibrations and controls for colorimetric tests.
5.3.1. To Order Calibration
Follow this procedure to register calibration in the worklist.
If using different calibrators, follow the procedure given below as example for each calibrator
registration. Modify Sample field, MS field and No. field according to your needs.
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1. Select an empty position in the worklist.

2. Select Multistandard (example) from the Type dropdown list.
3. Select the sample category (Common, Serum, Plasma or Urine) from the Sample dropdown list:
Common (example).
4. Select MCAL (example) from the MS dropdown list.
5. Select Full for full calibration or the calibration point number for one point calibration from the No.
dropdown list.
6. Select the tests to calibrate.
7. Press Save.
An automatic SID (950000XX) is assigned to the calibrators. Instrument automatically assigns the
appropriate positions for multipoint calibrations in accordance with the registered calibration for
each test.
If using a calibrator with a serial dilution registered, select Serial Dilution from the Type
dropdown list.
See also:
■ Sample Identification Code, p.154
5.3.2. To Order Control
Follow this procedure to register control in the worklist.
1. Select an empty position in the worklist.

2. Select Control from the Type dropdown list.
3. Select the appropriate control from the Control dropdown list.
4. Select the tests.
5. Press Save.
An automatic SID (970000XX) is assigned to the controls.
See also:
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5.3.3. To Load Calibrator and Control
Follow this procedure to load calibrator and control on the sample tray.
Place calibration and control solutions in sample cups.

2. Press the >> button below the worklist.
3. Load calibrators and controls according to the worklist.
a. Remove the Sample and Reagent Container Unit (SRCU) cover.
b. Load sample cups with adapter on the sample tray.
■ Ensure that a sufficient sample volume without air bubble or foam is placed on
the instrument (refer to Workflow > Sample Materials chapter).
■ Caps must be removed from the sample cups as they may hit the Sample and
Reagent Container Unit (SRCU) cover.
Samples can be placed on the sample tray without removing the sample tray from
the SRCU.

5. Check that the probe has no obstacle on its way.
See also:
■ Sample Materials, p.76
5.3.4. To Start Measurement
Follow this procedure to start measurements.
Before you start measurements, the following conditions must be fulfilled:

■ Enough new cuvettes must be loaded on the instrument.
■ Dust pod must allow to store cuvettes used during measurements.
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■ Reagents, diluents and wash solutions are on board and enough for ordered measurements.
■ Check that the water tank is full, if not fill it up with distilled water.
■ Check that the water tubing end stands in the bottom of the water tank.
■ Check that the waste tank is empty, if not empty it.
■ The cover of the Sample and Reagent Container Unit (SRCU) must be closed.
■ The instrument main cover must be closed.
■ The STAT unit must be closed.
1. Press Start button for more than two seconds.

The Start button is displayed at the top of each screen.
If not enough cuvettes on board, the message "Shortage of cuvette or disposal space
for all orders. Continue the measurement?" is displayed.
A pop-up is displayed: "Conduct DTR automatic measurement?".
2. Press OK.
The autogain measurement of the spectrophotometer is only performed for the first
measurement of the day.
A pop-up is displayed: "Preparing for measurement start".
If not enough reagent to perform the ordered tests, the instrument displays the
following pop-up: "Reagent inventory may be insuficient to process all test ordered,
continu measurement?"
The instrument starts measurement and the status "ANALYSING" is displayed.

The instrument displays the start time and the estimated finish time for measurements in the main
screen.
5.4. Check of Calibration and Control Results
5.4.1. To Check Calibration and Control Results
Follow this procedure to check calibration and control validity.
Access: Main menu > Run
During measurements and when run is complete, the Run screen displays calibration and control results.
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1. Check for calibrations validity in the Calibration tab.

■ If an error is displayed for a calibration, the calibration and the controls associated must be rerun.
■ If no error is displayed, check for the controls validity.
2. Check for controls validity in the Control tab.

■ If an error is displayed for a control, the control must be rerun.
■ If no error is displayed, samples can be run for the test.
To rerun calibrations and controls, open the Selection tab ( Main menu > Order >
Selection (tab) ). Select the position of the tube in the worklist and unselect the tests that
do not need to be rerun. Delete from the list calibrators and controls that are valid.
If after rerunning calibrations and/or controls the error persists, please refer to the
troubleshooting procedure. See Maintenance and Troubleshooting > Troubleshooting
chapter.
See also:
■ Results Screen, p.120
■ Error Flags, p.302
■ Troubleshooting, p.252
5.4.2. Run Screen
In the Run screen, the Calibration tab and the Control tab display respectively all the calibration
results and all the control results from the run as soon as they are available.
Access: Main menu > Run
Calibration results are displayed as soon as the measurement is finished for each calibration point.
Control results are displayed as soon as the measurement is finished for each control result.
Calibration as control results are sorted by availability.
At the beginning of the next run, all results from the previous run are deleted from the Run screen.
A table displays the following information:
Legend Description
Pos Calibrator or control position on the sample tray.
PID Calibrator or control name.
SID Calibrator or control ID number.
Method Method name.
Result Measurement result (mAbs/10).
Error Error flag.
If more than 16 results are displayed, you can navigate on the different pages of results using the
Previous Page and the Next Page buttons.
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See also:
■ To Check Calibration and Control Results, p.103
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6. Patient Samples
6.1. To Order Patient Samples
Follow this procedure to run patient samples.

2. Open the Sample and Reagent Container Unit (SRCU) cover.
3. If necessary remove all the tubes from the sample tray.
4. If necessary delete all the tubes from the worklist in the Selection screen:
5. Register samples in the worklist according to your sample management method.

■ Sample position registration,
■ Sample registration with barcode,
■ Sample registration with host connection (LIS).
15 positions are available on the sample tray. A 16th position is available in the STAT
unit. If the STAT unit position is used for normal sample, no emergency tests will be
available during the run.
See also:
■ Sample Registration, p.111
■ To Register Samples by Position, p.107
■ To Register Samples with Barcode, p.108
■ To Register Sample with Host Connection (LIS), p.109
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6.1.1. To Register Samples by Position
Follow this procedure to register patient samples if not using barcode nor host connection.
If necessary, register patient data in the Patient screen before sample registration ( Main menu >
Order > Patient (tab) ).
1. Select an available position in the worklist ( Main menu > Order > Selection (tab) ).
2. Select Normal in the Type dropdown list.
3. Select the cup type (Normal or Biocup) from the Cup dropdown list.
When a sample is registered, the instrument automatically gives a SID corresponding to the
sample position on the tray.
4. If using a SID, type the SID in the SID field (up to 12 digits).
After saving the sample registration, the instrument automatically selects the next
position on the tray and the SID is automatically incremented.
5. If using a PID, select the corresponding patient in the PID field.

6. Select the sample category (Common, Serum, Urine, Plasma).
7. If necessary select patient range.
8. Choose tests to run for the selected sample by checking the corresponding tests.
9. Press Save to save sample registration.
10. Repeat the procedure for each sample to register.
11. If all the samples are registered in the worklist, press >> to check the worklist and the
corresponding sample position and ID.
12. Load the samples on the sample tray according to the worklist.
■ Ensure that a sufficient sample volume without air bubble or foam is placed on the
instrument (refer to Workflow > Sample Materials chapter).
See also:
■ To Register a Patient, p.150
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6.1.2. To Register Samples with Barcode
Follow this procedure to register a sample tube displaying a barcode.
If necessary, register patient data in the Patient screen before sample registration ( Main menu >
1. Select the empty position in the Start Pos field (top of the dropdown list).
2. Select Normal in the Type dropdown list.
3. Select the cup type Normal from the Cup dropdown list.
4. Type the barcode in the SID field.
5. If using a PID, select the corresponding patient in the PID field.
7. Select patient range.
9. Save sample registration.
The sample registered appears in the worklist below the STAT position 16 (E) at the bottom of the
list.
10. Repeat the procedure for each sample to register.

11. Load the samples on the sample tray.
■ Samples registered by this method stay in memory from run to run as long as they are
not run.
■ When you start the run, the instrument scans the tubes for barcode identification and
assigns the corresponding positions on the sample tray to each tube.
New registration cannot be performed during analysis.
See also:
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6.1.3. To Register Sample with Host Connection (LIS)
Follow these procedures to register samples with a host communication mode set on "On
Line Batch" or "On Line Query".
The host communication mode is set in the Host Connection screen ( Main menu > Services >
System Configuration > Host Connection (tab) ). Three communication options are available:
■ Off Line
■ On Line Batch
■ On Line Query
1. If the host communication mode is set to On Line Batch:

a. If starting a day of work, press Acquire Orders from the Selection screen. The next orders
during the day are automatically acquired by the system.
The worklist registered on the laboratory information system is loaded or updated on the
instrument.
b. Load the samples on the sample tray.
2. If the host communication mode is set to On Line Query, load the samples on the sample tray.
When a sample tube is detected on board, the instrument automatically checks for orders
registered on the laboratory information system and loads orders concerning the tube on the
instrument.
■ Caps must be removed from the sample cups as they may hit the Sample and Reagent
Container Unit (SRCU) cover.
See also:
■ LIS Connection Configuration, p.145
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6.1.4. Selection Screen
6.1.4.1. Selection Overview
The Selection screen allows you to register the tubes placed on the sample tray or on the STAT
position and to associate them with the analysis to perform.
1 = Sample
position on the
sample tray
2 = Sample details
and orders
3 = Button to
expand or
collapse the list
Tubes registered on the sample tray are displayed in the worklist on the left side of the screen. The
worklist can be expanded to display more information by pressing the >> button at the bottom of the
list.
Details and full description of the fields are available in Workflow > Patient Samples > To Order Patient
Samples > Selection Screen > Sample Registration chapter.
See also:
■ Sample Registration, p.111
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6.1.4.2. Expanded Worklist
1 = Button to
expand or
collapse the list
2 = Emergency
position (STAT)
The expanded worklist displays the following information:
Legend Description
Pos Sample position on the sample tray.
SID Sample ID.
PID Patient ID for samples, calibrator name for standards, control name for controls or
the type of action to be performed.
Cup Type of cup used. N: normal tube. B: biocup.
Type Measurement type:
■ N: Normal
■ E: STAT
■ S: Standard
■ M: Multi-standard
■ C: Control
■ O: Online
■ R: Replicate
■ D: Serial Dilution
■ ICa: ISE calibration
■ ICl: ISE Cleaning
■ ICl2: ISE Cleaning 2
■ IAct: ISE activation
Sample Sample category (Common, Serum, Urine, Plasma).
Range Patient range.
Num Number of replicates ordered.
6.1.4.3. Sample Registration
15 positions corresponding to the sample tray positions are available in the worklist. A 16th position
(E) is the emergency position (STAT). Only STAT or normal samples can be ordered on that position.
For sample registration using a barcode, the registered samples are displayed in the worklist below
the STAT position 16 (E) at the bottom of the list. They are automatically moved to their physical
position on the sample tray when the barcode is checked at the beginning of the run.
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When the worklist is collapsed, details of each order can be displayed in the sample details area.
Select a sample from the worklist by pressing on it. The details are automatically displayed in the
sample details area.
To register a new sample in the worklist, please refer to one of the following chapters according to
your sample management method:
■ Sample position registration, see Workflow > Patient Samples > To Order Patient Samples > To
Register Samples by Position chapter,
■ Sample registration with barcode, see Workflow > Patient Samples > To Order Patient Samples >
To Register Samples with Barcode chapter,
■ Sample registration with host connection (LIS), see Workflow > Patient Samples > To Order Patient
Samples > To Register Sample with Host Connection chapter.
To edit an order, press on the sample position, make the required changes and save.
Details and options available for registration
Depending on the measurement type selected, the fields displayed may vary to fit with the
measurement type needs.
Legend Description
Start Pos Position on the sample tray for sample registration.
If the blank position is selected, the barcode available on the sample tube is
considered. Only available for the following sample types:
■ Normal
■ STAT
■ Replicate
■ Online
End Pos End position. Only available when the C/D check box is selected to copy or to
delete samples.
Number Number of replicates (from 1 to 99). If more than two replicates are ordered for a
sample, no rerun of the sample is performed. This field is available only if the type
of measurement Replicate is selected.
C/D Copy or delete option using Start Pos combined with End Pos or SID:
■ To copy a sample order from a start position to an end position: specify both
positions, register the sample information, select the tests to be performed
and press Save. The same sample configuration is saved for all the positions
included and the SID is automatically incremented.
■ To delete samples from a start position to an end position: specify both
positions, press Delete and then Save. All samples registered for the
positions included are deleted.
■ To copy a sample order from a start SID to an end SID: specify the start SID
(the second SID field) and the end SID (the third SID field). Register the
sample information, select the tests to be performed and press Save. The
same sample configuration is saved for all the SID included and the SID is
automatically incremented until the end SID.
Type Measurement type (Normal, STAT, Multi-Standard, Standard, Control, Online,
Replicate, Serial Dilution, ISE Calibration, Blank, ISE Cleaning, ISE Cleaning 2, ISE
Activation).
Cup Sample tubes (Normal, Biocup)
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Legend Description
SID Sample ID. Three fields are available for SID:
■ The first field: the SID prefix is automatically displayed for normal tubes
according to the specified upper sample number in the Setup screen ( Main
menu > Services > System Configuration > Setup ).
■ The second field: the sample position on the sample tray is automatically
displayed. The position can be deleted to register a specific SID. If the C/D
check box is selected, the field corresponds to the first SID.
■ The third field: only available when the C/D check box is selected, the field
corresponds to the last SID to copy or to delete.
Sample Sample category (Common, Serum, Urine, Plasma).
PID Patient ID can be selected from the dropdown list if already registered.
Range Patient range used for results judgement can be selected from the dropdown list
if already registered. If not specified, the male-G2 range is used. See Settings >
Patient and Sample Information Configuration > To Configure Patient Range
chapter.
Sample Comment Patient comment can be selected from the dropdown list if already registered.
Location Location can be selected from the dropdown list if already registered.
Physician Physician can be selected from the dropdown list if already registered.
Other fields can be displayed according to the type of measurement selected:

Multi-Standard
Legend Description
MS Multi-standard can be selected from the dropdown list if already registered.
No. Select from full calibration or partial calibration on the first calibration point (S1) or
the specified calibration point (Sn).
Control
Legend Description
Control Control can be selected from the dropdown list if already registered.
Tests selection
Each sample needs to be associated with at least one test to be saved in the worklist. To define the
tests for a sample, select the corresponding check box. The tests have a color code according to their
status.
If a cassette used for a test is not on board, the test is not displayed.
Color Status Action

Register the reagent and the cassette used for
No test The test is not displayed. the concerned test.
Turns to
Calibration is not valid or User needs to run a new calibration.
Red background:
required. Turns to when selected
User needs to run a new control.
Yellow background: Control error or required.
Turns to when selected
Select the Mask tab (in Main menu > Order )
The test is masked and will not
Grey Background: and unselect the mask for the concerned test.
be run.
Turns to
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Color Status Action

The test is available for
No background: measurements. Calibration and Turns to when selected
controls are valid.
Online registration
The Type dropdown list allows to select the online mode for orders received from the host
connection. If the orders from the host are not in the worklist, they can be downloaded from the host
by pressing the Acquire Orders button. The worklist is automatically updated with all the pending
data from the host. If using a barcode, the samples registered are displayed at the bottom of the
worklist and are allocated to their physical position at the beginning of the run. If not using barcode,
the SID must be registered for each position before receiving the order from the host.
ISE sequence orders

Specific actions for the ISE module can be ordered from the Selection screen. They are not executed
by pressing the Start button but by using a specific button for each action in the Customer Services
screen ( Main menu > Services > Customer Services > Sequence ).
See also:
■ To Check Calibration and Control Validity, p.100
■ To Order Patient Samples, p.106
■ To Register a Location, p.148
■ To Register a Physician, p.147
■ To Register a Sample Comment, p.149
■ To Configure Patient Range, p.152
■ To Order Patient Samples, p.106
■ To Register Samples with Barcode, p.108
6.1.5. To Start Sample Measurement
Follow this procedure to start measurements.
Before you start measurements, the following conditions must be fulfilled:

■ Enough new cuvettes must be loaded on the instrument.
■ Dust pod must allow to store cuvettes used during measurements.
■ Reagents, diluents and wash solutions are on board and enough for ordered measurements.
■ Check that the water tank is full, if not fill it up with distilled water.
■ Check that the water tubing end stands in the bottom of the water tank.
■ Check that the waste tank is empty, if not empty it.
■ The cover of the Sample and Reagent Container Unit (SRCU) must be closed.
■ The instrument main cover must be closed.
■ The STAT unit must be closed.
Press Start button for more than two seconds.

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If not enough cuvettes on board, the message "Shortage of cuvette or disposal space for
all orders. Continue the measurement?" is displayed.
A pop-up is displayed: "Preparing for measurement start".
If not enough reagent to perform the ordered tests, the instrument displays the following
pop-up: "Reagent inventory may be insuficient to process all test ordered, continu
measurement?"
The instrument starts measurement and the status "ANALYSING" is displayed.

The instrument displays the start time and the estimated finish time for measurements in the main screen.
6.2. To Run Emergency Sample
Follow this procedure to load an emergency sample when the instrument is already
analysing samples.
STAT position on the left-hand side of the instrument is dedicated to emergency samples.
For the STAT position, sample height within the tube must be higher than 12.6 mm.
1. Press for more than two seconds the STAT button from the generic toolbar.
This action enables you to open the STAT unit. Open the STAT unit when the status changes from
"ANALYSING" to "WAITING".
2. Open the STAT unit by pushing slightly on the STAT cover on the left-hand side of the instrument.
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3. Insert the emergency sample (sample tube or sample cup with adapter) and push the STAT unit
back into the instrument.
4. Select position 16 from the Start Pos dropdown list and Normal from the Type dropdown list in
the Selection screen.
5. Select the cup type (Normal or Biocup) from the Cup dropdown list.
6. If using a SID, type the SID in the SID field (up to 12 digits).
7. If using a patient ID, select the corresponding patient in the PID field.
9. Select the patient age range.
11. Press Save to save emergency sample registration.
12. Press Start for more than two seconds.
The emergency sample requested is run in priority before any remaining samples from the worklist.
■ Only one emergency sample can be run during a run.

■ No barcode reader is available for emergency sample. You must enter information
manually in the worklist.
Wait until the end of the run to remove the emergency sample tube.
See also:
■ STAT Sample Status, p.48
■ Sample, p.310
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6.3. To Check Results
6.3.1. Display of Current Results
6.3.1.1. To Display Current Results
Follow this procedure to check the results from the current run.
Access: Main menu > Run > Patient (tab)
Results are displayed in the Run screen as soon as the measurement is done.
1. Check the results from the run in the Patient tab from the Run screen.
Only on this screen, the instrument adds to the SID of each sample a prefix
corresponding to the sample type and the cup type (N for normal cups, n for biocups,
E for emergency samples and R for replicates).
2. If results are flagged, please refer to Workflow > Patient Sample > To Check Results > To Manage
Flagged Results chapter.
■ Results from the run are automatically transferred to the Results screen.
■ When a new run is started, results from the previous run are deleted from the Run screen.
See also:
■ To Manage Flagged Results, p.124
6.3.1.2. Run Screen
In the Run screen, the Patient tab displays all the patient results from the run as soon as they are
available.
Access: Main menu > Run > Patient (tab)
Results are sorted by availability.

At the beginning of the next run, all results from the previous run are deleted from the Run screen.
A table displays the following information:
Legend Description
Pos Sample position on the sample tray.
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Legend Description
PID Patient ID number.
SID Sample ID number.
Method Method name.
Result Measurement result (concentration).
Unit Results unit.
Error Error flag.
If more than 16 results are displayed, you can navigate on the different pages of results using the
Previous Page and the Next Page buttons.
See also:
6.3.2. Check or Print of Results from the Results Screen
6.3.2.1. To Check or To Print Results from the Results Screen
Follow this procedure to check results from a previous run or to print results.
Access: Main menu > Results
1 = SID/PID dropdown list
2 = SID/PID fields
3 = Date management area
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4 = Output selection area
5 = Search button
6 = Results information area
1. Select SID or PID from the SID/PID dropdown list.

2. Type the SID or PID corresponding to the desired patient results.
In some cases, the SID is changed by the instrument:

■ For normal samples, the SID is not changed by the instrument. Type the SID you
registered for the sample.
■ For emergency samples, type the prefix 99000 before the registered SID.
■ For replicates, type the prefix 9400 before the registered SID.
■ Use "*" to select all the SID or PID.
3. Select the period or the date to display in the Date management area.
4. Select Monitor from the Result Output dropdown list.
5. Press Search to display the results on the screen.
6. Check results in the results information area.

7. If results need to be printed:
a. Select Condensed report from the Result Output dropdown list.
b. Press Search more than one second to print the results report. A printer in ready mode needs
to be connected to the Pentra C200 (option).
To print standard report, first select Normal from the Sample Type dropdown list, then
select Standard report from the Result Output dropdown list.
8. If results are flagged, please refer to Workflow > Patient Sample > To Check Results > To Manage
Flagged Results chapter.
See also:
■ To Manage Flagged Results, p.124
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6.3.2.2. Results Screen
The Results screen displays all the results obtained on the instrument.
Access: Main menu > Result
1 = Search area
2 = Output
selection area
3 = Results detail
area
4 = Raw data
selection area
5 = Results table
Search area
The search area allows to search the results according to several search options. A combination of
the different options is recommended to narrow the results number. If result number exceeds 2000,
the results are not displayed and the search criteria must be narrowed.
Search criterion Field / Button Description

Sample type Sample Type dropdown Select the sample type corresponding to your search:
list
■ All: all results are output
■ Normal: normal sample type
■ STAT: emergency samples
■ Online: samples ordered by a host connection
■ Standard: calibrator samples (include serial dilution,
multi-standard and blank)
■ ISE Standard: ISE calibration
■ Control: control samples
■ Replicate: samples ordered as replicates
Sample ID SID/PID dropdown list The fields From and To allow to select a specific SID or a
group of SID (12 digits):
■ All SID: input "*" in both fields,
■ A specific SID: input the same SID in both fields,
■ A group of SID: input the lower SID in From field and
the higher SID in To field.
Patient ID SID/PID dropdown list The fields From and To allow to select a specific PID or a
group of PID (20 digits):
■ All PID: input "*" in both fields,
■ A specific PID: input the same PID in both fields,
■ A group of PID: input the lower PID in From field and
the higher PID in To field.
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Search criterion Field / Button Description

Sample category Sample dropdown list Select the sample category corresponding to your search:
■ Common
■ Serum
■ Urine
■ Plasma
Date of measurement Date From and Date To The fields date allow to select a specific date to display or
dropdown list a period:
■ A specific day: select the same date for both fields,
■ A determined period: select a date for both fields,
■ A period from a specific date to the current date:
select a date in the From field and check the Disable
check box for the end date,
■ A period before a specific date: check the Disable
check box for the From field and select the end date
in the To field.
Run number Run # field The field Run # allows to select results from a specific run
or results from all the runs:
■ A specific run: input the run number from 1 to 99,
■ All runs: input "*".
Method Select Test button To specify a search for one or several methods, press the
Select Test button. A pop-up displays all the methods
available. Methods are in blue when selected. Press a
method to select or unselect it or use the Select All
button and the Clear All button. Press OK to validate the
selected tests.
Host transmission Criter. dropdown list The field Criter. allows to select the results that have
been successfully sent or not to the host:
■ All: all results,
■ Not Sent: results that have not been sent successfully
to the host,
■ Sent: results that have been sent successfully to the
host.
The output format of the results must be specified before to start the search.
Output destination
Results can be either displayed on the screen, printed, saved as file on a USB key or the raw data can
be saved on a USB key. Select the output destination from the Result Output dropdown list.
■ Monitor: displays the results on the screen.
■ Condensed report: if a printer is connected (option) and the instrument is in "READY" status,
results are printed when the green Search button is pressed (more than one second). Printed
results include the concentration, the unit, the flags and the cassette lot number.
■ Standard report: if a printer is connected (option) and the instrument is in "READY" status, results
are printed with a report format when the green Search button is pressed (more than one second).
Results on the report are displayed as a table with the list of methods and for each of them the
unit, the concentration, the flags, the cassette lot number and the normal range.
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Condensed report
Standard report
The report format is only available when Normal, STAT and Online sample types are
selected in the Sample Type field.
■ File: the results are saved to a USB key. The destination folder must be specified using the
directory access button. Saved results include the date, the run number, the PID, the SID, the
concentration value and the flag. The file is saved in .CSV format (spreadsheet program compatible).
■ Raw data (File): all the raw data are saved to a USB key. The destination folder must be specified
using the directory access button. Each kinetic is saved in a specific .CSV file (spreadsheet
program compatible).
Functions
The Search button allows you to search by criteria specified and:
■ To display the results on screen,
■ To print the results,
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■ To save the results on USB key,

■ To send the results to the host.
The Delete button allows to delete the results from the database according to the search criteria
specified. The delete function is only available for L2 users.
Results table
The results found in the database according to the search criteria are displayed in a table. Each line
displays all the results for one sample.
Legend Description
Date Date of measurement (mm/dd/yyyy).
Run Run number.
PID Patient ID or for control the control name.
SID Sample ID.
Method Methods used on the selected samples are displayed as several rows. Results are
displayed in concentration.
For calibration results a specific table is displayed:
Legend Description
Date Date of measurement (mm/dd/yyyy).
Run Run number.
Method Display the list of methods concerned by calibration.
SID Calibrator ID.
Sn Results for the different calibration points (Sn).
Results details
The details of each result can be displayed in the results details area. To display details, select a result
by pressing on it in the results table. Only one result must be selected to display the details.
Legend Description
Result Displays the concentration.
Judgement Displays the normal range judgement ("H" or "L").
Range Displays the technical range judgement ("<" or ">").
Flag Displays the error flags.
R1L Displays the reagent 1 (R1) lot number.
ABS Displays the absorbance value (not for ISE results).
Error Code Displays the error code for ISE results. For results without error code "0000" is displayed.
Delete Deletes the selected result.
For calibration results specific details are displayed:
Legend Description
Result Displays the result of the calibration point (absorbance for end point methods and rate for
rate methods).
Judgement Displays the normal range judgement ("H" or "L").
Range Displays the technical range judgement ("<" or ">").
Flag Displays the error flags.
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Legend Description
Lot # Displays the calibrator lot number.
Conc(S) Displays the registered concentration for the calibration point.
Delete Deletes the selected calibration point.
Error flags are only displayed in the Run screen and the Results screen.
Raw data
The raw data can be either displayed on the screen, printed or saved.
■ Graph: the raw data are displayed on a pop-up. In the raw data window, you can choose to
display the primary wavelength, the secondary wavelength or the difference between both
wavelength. The scale can be adjusted.
■ Print: the raw data are printed if a printer is connected to the instrument (option). Press more than
one second to print.
■ File: the raw data are saved to a USB key. The file is saved in .CSV format (spreadsheet program
compatible).
See also:
■ To Check Calibration and Control Results, p.103
6.3.3. To Manage Flagged Results
Follow this procedure for results which are flagged with an error.
Samples which display an error flag are still registered in the worklist.
1. Check sample tubes.

2. If necessary, rerun the test:
a. Check that the samples to be rerun are in the worklist.
b. Select the tests to rerun for each sample.
c. If necessary delete samples which do not need to be rerun.
d. Press Start more than two seconds to start measurements.
See also:
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7. End of Day
After a day of work, the user needs to remove the samples, to delete the worklist and to perform the
instrument cleaning with the daily maintenance procedures.
If a printer (option) is connected to the instrument, it can be switched off.
7.1. To Empty the Worklist
Follow this procedure to delete the worklist after every day of work with the instrument.
After a day of work, before performing the instrument cleaning, the worklist needs to be deleted and
the samples removed from the Sample and Reagent Container Unit (SRCU).
1. Check the worklist.

If samples are still registered in the worklist, check that they do not need to be run or rerun.
2. If samples remain in the worklist and no test needs to be ordered for them:
3. Open the main cover and the SRCU cover.

4. Remove the tubes from the sample tray.
At the end of the week, you must perform the weekly procedure described in the
Maintenance and Troubleshooting > Maintenance > Weekly Procedures chapter .
See also:
■ Weekly Procedures, p.201
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7.2. To Clean ISE with Etching (Option)
Follow this procedure every day if running more than 20 samples per day on the ISE unit.
If running less samples, ISE cleaning needs to be performed once a week, at the end of
the week.
7.2.1. To Load Etching Solution on the Sample Tray
Follow this procedure to load on board the Etching solution for ISE cleaning.
■ Disposable gloves must be worn by the operator.

■ Tools and consumables used during this procedure: Etching solution (ABX Pentra Etching CP
A11A01769).

3. Pour 2 mL of Etching solution from an Etching cassette (ABX Pentra Etching CP A11A01769) into
a tube.
4. Place the Etching tube at position 14 in the sample tray.
7.2.2. To Perform the ISE Cleaning
Follow this procedure to clean ISE module with Etching.
1. Select position 14 from the Selection screen.

2. Select ISE Cleaning2 from the Type dropdown list.
3. Press Save to save the ISE cleaning registration.
4. Open the Sequence screen ( Main menu > Services > Customer Services > Sequence (tab) ).
5. Press ISE Cleaning2.
The instrument status changes from "READY" to "ANALYSING". ISE cleaning lasts approximately
seven minutes. When finished, the instrument status switches back to "READY".
6. Wait until the instrument is in "READY" status and remove the Etching tube from the sample tray.
7. Delete the worklist:
a. Open the Selection screen ( Main menu > Order > Selection (tab) ).
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b. Press Delete All.

c. Press Save to validate the deletion.
Always perform an ISE activation after ISE cleaning.
7.2.3. To Perform an ISE Activation
Follow this procedure to perform an ISE activation after ISE cleaning or after electrode
exchange.

3. Place a serum or a plasma sample in an available position in the sample tray.
4. Select the sample tray position with the serum or the plasma tube.
5. Select the ISE Activation from the Type dropdown list.
6. Press Save to register the ISE activation.
9. Open the Sequence screen ( Services > Customer Services > Sequence (tab) ).
10. Press ISE Activation.
Wait until the end of the ISE activation: instrument status changes from "ANALYSING" to "READY".
7.3. To Check System Solutions
1. Check that the water tank is full, if not fill it up with distilled water.
2. Check that the water tubing end stands in the bottom of the water tank.
3. Check that the waste tank is empty, if not empty it.
■ During the instrument operation, do not remove the waste liquid tube under any
condition.
■ Waste must be handled according to your local/national regulations.
4. If the instrument is equipped with an ISE module (option), check ISE solutions before a prolonged
stand-by period within four days (over the week-end).
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a. In Services > Customer Services > WorkHour (tab) check the remaining volume for Standard
1 and Reference solutions.
b. If the volume is lower than 28 mL for Standard 1 solution or 10 mL for Reference solution,
replace the bottle with a new one.
If the instrument is not used for more than four days, perform an extended shutdown
with ISE. Please refer to your user manual, see Maintenance and Troubleshooting >
Maintenance > Other Procedures > To Perform an Extended Shutdown with ISE chapter.
See also:
7.4. To Clean Sample and Reagent Container Unit
Follow this procedure every day to clean and to remove condensation from the Sample
and Reagent Container Unit (SRCU).
According to your geographical location, the SRCU may have condensation and may need to be
wiped after every day of work.
To follow the SRCU cleaning procedure, please refer to the maintenance chapter. See Maintenance
and Troubleshooting > Maintenance > Daily Procedures > To Clean Sample and Reagent Container
Unit chapter.
See also:
■ To Clean Sample and Reagent Container Unit, p.199
7.5. To Clean the Probe with Deproteinizer
Follow this procedure to automatically clean the probe after every day of work.
Access: Main menu > Inventory > Reagent Tray (tab)

■ Tools and consumables used during this procedure: Deproteinization solution (ABX Pentra
Deproteinizer CP A11A01754).
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Every two weeks, perform tubing and tank decontamination before probe cleaning.
1. Check that a valid Deproteinizer cassette (ABX Pentra Deproteinizer CP A11A01754) is on board.
2. If no Deproteinizer cassette is on board:
a. Load a Deproteinizer cassette on the reagent tray.
b. Open the Inventory screen.
c. Perform a barcode scan.
3. Enter in sleeping mode to start the probe cleaning with deproteinizer (see Workflow > End of Day >
Sleeping Mode > To Enter Sleeping Mode chapter).
The probe cleaning starts by entering in sleeping mode. It consists of a 10-minute presoak of the
probe in the deproteinizer solution dispensed in a cuvette.
See also:
■ Sequence, p.244
■ To Switch Off the Instrument for Maintenance Procedures, p.208
■ Sleeping Mode, p.129
7.6. Sleeping Mode
Follow these procedures to configure the sleeping mode, to enter the sleeping mode, to
perform a manual wake up.
7.6.1. To Set Sleeping Mode
Follow this procedure to check or to configure the sleeping mode settings.
Access: Main menu > Services > Customer Services > Sleep (tab) > Daily (tab)
The user needs to configure the sleeping settings for each day of the week. This configuration defines
the wake up hour, the priming at wake up and the wash procedure at wake up.
1. Check the wake up hours in the Daily screen.

2. If necessary change the wake up hours by pressing the partial keyboard access button.
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3. Select the preparation mode for wake up:

a. Select OFF for a day off.
b. Select Prep2 for a day of work after a day off.
c. Select Prep1 for other days of work.
4. Open the Sleep Setting screen which allows to program the wake up cycles.
5. Select 1 for Prep1 primes and 2 for Prep2 primes.
6. Select 0 for all Special Probe Wash options.
7. Select ON for RCU Refrigeration to allow the Sample and Reagent Container Unit (SRCU) to be
refrigerated during sleeping mode.
If there is too much condensation in the SRCU, select OFF for RCU Refrigeration,
remove the trays from the SRCU and keep them in the fridge during sleeping mode.
8. Press Save to save Daily and Sleep Setting modifications.
7.6.2. To Enter Sleeping Mode
Follow this procedure to enter sleeping mode.
Access: Main screen
1. Press the Shutdown button in the generic toolbar at the top of the main screen.
2. Press Sleep.
A pop-up is displayed to allow the probe wash configuration.
3. Configure the Presoak Probe Wash area:

a. Press ON.
b. Press S for special wash (W: water wash, D: DET.W wash).
c. Press OK to start the probe wash.
Instrument displays a pop-up to warn the user that the preparation of sleep operation is processing
and performs probe wash with the deproteinizer solution.
The instrument switches to sleeping mode when the cleaning is finished. In sleeping mode the green
LED is blinking and the screen is black.
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7.6.3. To Perform a Manual Wake Up
Follow this procedure to wake the instrument up before the automatic wake up.
1. Press the touch screen to wake the instrument up.

The main screen is displayed and the instrument status is "ANALYSING".
2. Press the Shutdown button in the generic toolbar at the top of the screen.
3. Press Sleep Cancel from the pop-up.

4. Press OK to confirm wake up from the pop-up: "Conduct the cancel of sleep operation?".
The instrument performs an initialization.
The scheduled wash from the automatic wake up is performed at the beginning of the first
run.
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Settings
1. Managing Users Accounts..............................................................................................134

1.1. To Register a New User..........................................................................................................135
1.2. To Delete a User.....................................................................................................................136
1.3. To Change User's Password..................................................................................................136
1.4. To Change User's Level..........................................................................................................137
2. System Settings...................................................................................................................138
2.1. To Set Date and Time.............................................................................................................138
2.2. To Configure Audible Alarm....................................................................................................138
2.3. To Configure Printer Reports..................................................................................................139
2.4. To Configure the Auto Backup...............................................................................................141
2.5. To Set Sleeping Mode............................................................................................................142
2.6. General Settings Configuration...............................................................................................143
2.7. Sample Barcode Configuration...............................................................................................144
2.8. LIS Connection Configuration.................................................................................................145
3. Patient and Sample Information Configuration......................................................147

3.1. To Register a Physician..........................................................................................................147
3.2. To Register a Location............................................................................................................148
3.3. To Register a Race..................................................................................................................149
3.4. To Register a Sample Comment.............................................................................................149
3.5. Patient Registration.................................................................................................................150
3.6. To Configure Patient Range....................................................................................................152
3.7. To Configure Age Range.........................................................................................................153
3.8. Sample Identification Code.....................................................................................................154
4. Application Configuration................................................................................................155
4.1. Reagent Registration..............................................................................................................155
4.2. Application Parameters Registration......................................................................................158
4.3. To Configure ISE Parameters.................................................................................................177
4.4. To Configure Method to Method Calculation.........................................................................178
4.5. To Configure a Profile for a Group of Tests............................................................................180
4.6. To Configure a Mask...............................................................................................................181
4.7. To Configure the Methods Sequence.....................................................................................182
4.8. To Program Wash for Incompatibility.....................................................................................183
4.9. Calibration Settings.................................................................................................................185
4.10. Control Settings....................................................................................................................190
4.11. Code's Method Table...........................................................................................................193
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Managing Users Accounts
1. Managing Users Accounts
This chapter provides the procedures to register new users and to configure their operating level or to
change user's password.
Access: Main menu > Services > System Configuration > Password (tab)
Only level 2 users (L2) or engineer (EL) are allowed to register a new user, to delete a user,
to change user's password or to change user's level.
See also:
■ To Register a New User, p.135
■ To Delete a User, p.136
■ To Change User's Password, p.136
■ To Change User's Level, p.137
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1.1. To Register a New User
Follow this procedure to register a new user and to configure his operating level.
A total of 20 users can be registered on the instrument.
1. Press the arrow from the User Name dropdown list and check the list of users already registered
for the instrument.
2. Type the new user name in the User Name field.
3. Choose the level for the operating rights of the user in the User Level dropdown list.
Two levels are available for the users:
■ L1 user which is for the lab assistant in charge of the analysis,
Users L1 are not allowed:

■ To reset workhours counters,
■ To reset volumes of ISE solutions when bottles are changed,
■ To register new reagents,
■ To configure application parameters,
■ To delete control results,
■ To manage users.
4. Type the password in the New Password field.

5. Type the same password in the New Password Check field.
6. Press Save to register the new user account.
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1.2. To Delete a User
Follow this procedure to delete a user.
1. Press the arrow from the User Name dropdown list and select the user to delete.
2. Type the user's password in the Old Password field.
3. Press Delete.
1.3. To Change User's Password
Follow this procedure to change user's password.
1. Press the arrow from the User Name dropdown list and select the user.
3. Type the new password in the New Password field.
5. Press Save to register the new user's password.
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1.4. To Change User's Level
Follow this procedure to change user's level.
1. Press the arrow from the User Name dropdown list and select the user.
2. Choose the level for the operating rights of the user in the User Level dropdown list.
Two levels are available for the users:
■ L1 user which is for the lab assistant in charge of the analysis,
Users L1 are not allowed:

■ To reset workhours counters,
■ To reset volumes of ISE solutions when bottles are changed,
■ To register new reagents,
■ To configure application parameters,
■ To delete control results,
■ To manage users.

4. Type the new password in the New Password field.
6. Press Save to register the new user's level.
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System Settings
2. System Settings
2.1. To Set Date and Time
Follow this procedure to set the current date and time on the instrument.
Access: Main menu > Services > System Configuration > Setup (tab)
1. In the Date Setting area, type the date (mm/dd/yyyy) in the SystemDate field or select the date
from the calendar.
Press the arrow from the Date field to display the calendar. To choose a month, use the left and
right arrows. Then choose the day.
2. Set the SystemTime (hh:mm:ss) by selecting the field to change (hours, minutes or seconds) and
either type the new value or use the arrows to change the value.
3. Press Save to register the new date and time.
2.2. To Configure Audible Alarm
Follow this procedure to configure the audible alarms.
Access: Main menu > Services > System Configuration > Audible Alarm (tab)
1. Select the Enable Sound Run Complete option to get an audible alarm when the run is complete.
2. Choose the alarm volume from the dropdown list:
■ Off: no audible alarm.
■ 1-9: volume from 1 (min.) to 9 (max.).
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System Settings
2.3. To Configure Printer Reports
Follow this procedure to configure automatic reports printing and their content.
Access: Main menu > Services > System Configuration > Printer (tab)
This screen is only available for L2 users and engineers (EL).
1. Select the Enable option to automatically print the results when all the measurement for a specific
tube are performed.
2. Select the printing type and content:
■ Condensed: patient data, tests, results.
■ Standard: one patient per page.
3. Select the Enable Live QC Report option to automatically print the quality control results when
available.
4. Type the text of your choice in the five available fields to configure the header printed on each
report (one line of 20 characters and four lines of 50 characters).
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System Settings
Live print out condensed
Live print out standard
Live QC report
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System Settings
2.4. To Configure the Auto Backup
Follow this procedure to configure the automatic backup of the data and system
parameters after every day of work.
Access: Main menu > Services > System Configuration > Backup (tab)
Data and system parameters can be saved automatically on a USB key after every day of work. The
USB key must be connected to the instrument on port n°1, 2 or 3 and must have a minimum capacity
of 512 MB free.
Never use port n°4 to connect the USB key.
1 = System
parameters
backup
2 = Data
backup
3 = Database
management
4 = USB auto
backup
The automatic backup is performed during the shutdown: when entering in sleeping mode or when
Power Off is asked (optional). The instrument creates a backup folder for each day of work of the
week: "BackupSave-XXXX" where XXXX stands for the day of the week. The instrument overwrites the
folders from week to week.
1. To perform an automatic backup when the instrument enters in sleeping mode:

a. Select ON for every day of work in the USB Auto Backup area (4).
b. Select OFF for each day off.
The instrument automatically performs the data backup when the user asks the instrument to enter
in sleeping mode.
2. To perform an automatic backup when Power Off is asked:

Set the PowerOFF value to ON.
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System Settings
Never switch off the instrument with the main switch before the end of the backup.
2.5. To Set Sleeping Mode


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System Settings
2.6. General Settings Configuration
Only level 2 users (L2) are allowed to configure general settings. Save button must be
pressed for the new general settings configuration to be registered.
The Disable extrapolated results check box manages results calculation when results are outside of
the calibration curve.
■ If unselected, results outside of the calibration curve are calculated with a calibration curve
extended outside of the specified range.
■ If selected, the S1 (min.) or Sn (max.) values from the calibration curve are assigned to the results.
The Disable test without curve check box manages tests ordered without valid calibration curve for
the specified category of sample (Common, Serum, Urine, Plasma). The calibration curve used as
default calibration for any test without specific sample calibration curve is the calibration performed
on common sample.
■ If unselected, the calibration curve performed on common sample is used for any sample category
without calibration curve.
■ If selected, no default calibration curve is used and the test is not performed until a valid
calibration curve is available for this sample category (recommended).
The Enable Check Inventory check box allows the instrument to check reagents volumes available to
perform the ordered test. The instrument keeps in memory the volume of each cassette from the last
use of the cassette.
■ If selected, when the user press the Start button to start a run, the instrument checks the reagent
inventory in memory and compares with the reagent's need for ordered tests. If not enough
reagent to perform the ordered tests, the instrument displays the following pop-up: "Reagent
inventory may be insuficient to process all test ordered, continu measurement?"
■ If unselected, no comparison is performed at the beginning of the measurements between reagent
inventory in memory and reagent's need for ordered tests.
The Full compliance with ASTM rules check box specifies whether the data transfer to the host
computer applies to ASTM rules.
■ If selected, it applies to ASTM rules. Only the method-to-method calculation result is transmitted.
The rerun flags, QC results and QC flags are not transmitted.
■ If unselected, it does not apply to ASTM rules. The rerun flags, QC results, QC flags and method-to-
method calculation result are transmitted.
The ASTM ISE Separation check box selects the separation of ISE when specifying the order of ISE
from the host computer.
■ If selected, each electrolyte tested has its own test ID.
■ If unselected, all electrolytes tested have the same test ID.
Example:
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System Settings
Electrolytes Test ID with ASTM ISE Separation Test ID without ASTM ISE Separation
ISE (Na+) 61 61
ISE (K+) 62 61
ISE (Cl-) 63 61
The Overwrite result data check box manages the storage of data. The instrument has a storage
capacity of 10 000 results.
■ If selected, the last results overwrite the data from the instrument if storage capacity is full.
■ If unselected, the instrument does not start measurements if the storage capacity is full.
The BioCup check box manages the cup type (Normal or Biocup) selected by default in the Selection
screen ( Main menu > Order > Selection (tab) ).
■ If selected, Biocup is selected by default in the Cup dropdown list.
■ If unselected, Normal is selected by default in the Cup dropdown list.
The Enable Use Barcode check box manages the use of the barcode reader.
■ If selected, the barcode reader is active.
■ If unselected, the barcode reader is inactive. Samples can be ordered without barcode. Cassette's
barcode have to be registered manually.
The Reagent Code for Probe dropdown lists allow to define the special wash solution used during
probe wash (maintenance purpose on request or when entering in sleeping mode) when special wash
is selected ( Main menu > Services > Customer Services > Sequence (tab) ).
1. Choose the special wash solution (default setting: Deprot) from the list of reagents displayed in the
dropdown list. The reagents need to be registered in the Reagent screen ( Main menu > Services
> System Configuration > Reagent (tab) ) to be displayed.
2. Choose the reagent type (default setting: Wash) corresponding to the reagent selected.
The Remaining test calculation area configures the calculation method for the number of remaining
tests for each reagent. The calculation results of the number of remaining tests are displayed in the
Inventory screen as "Total" ( Inventory > Inventory ).
■ If Reagent Code is selected, the volume used for remaining tests calculation is the sum of all
reagent cassettes on board corresponding to the concerned reagent whatever the reagent lot
number.
■ If Reagent Lot is selected, volume used for remaining tests calculation is the sum of all reagent
cassettes on board with the same lot number corresponding to the concerned reagent.
See also:
■ Sequence, p.244
2.7. Sample Barcode Configuration
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System Settings
Only level 2 users (L2) are allowed to configure the use of check digit on sample barcodes.
Save button must be pressed to register the new sample barcode configuration.
The Sample Barcode C/D area allows to configure the use of check digit for barcode types CODE39,
Codabar (NW-7) and ITF2/5.
For each barcode type:
■ If ON is selected, the check digit is used for the corresponding barcode type. Only barcodes
integrating a valid check digit are accepted;
■ If OFF is selected, the check digit is not used for the corresponding barcode type.
The use of check digit for the barcode type CODE128 is not configurable, it is fixed with
check digit.
2.8. LIS Connection Configuration
Access: Main menu > Services > System Configuration > Host Connection (tab)
1 = Host
communication
mode
2 = Host details
mode
3 = Host
communication
Set the communication mode to the host computer in the Host Communication Mode area:
■ Off Line selected: the measurement is executed according to the settings of the instrument,
without communication with host computer.
■ On Line Batch selected: the measurements are executed according to the orders transmitted
from the host computer and the measurements results are sent to the host computer automatically.
■ On Line Query selected: starts to read the sample barcode label with communicating to host
computer every time. The measurements results are sent to the host computer automatically.
Set the host rerun mode in the Host Detail Mode area:
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System Settings
This setting is only available if the On Line Query option is selected.
■ No Re-query selected: host rerun is not executed.

■ Enable Re-query selected: additional tests required for the sample.
■ Enable Host Rerun selected: host rerun is executed only when the host computer requires rerun.
Choose the communication configuration methods of the connection to the host computer from the
dropdown lists in the Host Communications area:
Communication configurations Communication configuration methods Defaults

Baud Rate 19200, 9600, 4800, 2400, 1200, 300 bps 9600
Date Bit 7, 8 bits 8 bits
Stop Bit 1, 2 bit(s) 1 bit
Parity Bit None, Even, Odd Even
Protocol (E1381) Normal, No Handshake Normal
See also:
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Patient and Sample Information Configuration
3. Patient and Sample Information

Configuration
3.1. To Register a Physician
Follow this procedure to register the physicians.
Access: Main menu > Services > System Configuration > Define (tab)
Physicians must be registered to be displayed in the Physician dropdown list from the Order screen
( Main menu > Order > Selection (tab) ).
1. Select Physician from the Type dropdown list.

2. Press Add to register a new physician.
A data field is displayed below the Add button.
3. Type the name and surname of the physician (32 alphanumeric characters max.).
4. Press Save to save the physician registration.
The physician registered appears in the alphabetically ordered physicians list.
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A physician can be edited or deleted:

1. Press the physician name from the physicians list. The selected physician is displayed
below the contextual buttons.
2. Press Edit to edit the physician name or Delete to delete the physician from the list.
3. Press Save to validate the action.
3.2. To Register a Location
Follow this procedure to register locations.
Locations must be registered to be displayed in the Location dropdown list from the Order screen
1. Select Location from the Type dropdown list.

2. Press Add to register a new location.
3. Type the location (32 alphanumeric characters max.).

4. Press Save to save the location registration.
The location registered appears in the location list alphabetically ordered.
A location can be edited or deleted:

1. Press the location name from the locations list. The selected location is displayed
below the contextual buttons.
2. Press Edit to edit the location or Delete to delete the location from the list.
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3.3. To Register a Race
Follow this procedure to register races.
Races must be registered to be displayed in the Race list from the Order screen ( Main menu >
1. Select Race from the Type dropdown list.

2. Press Add to register a new race.
3. Type the race (32 alphanumeric characters max.).

4. Press Save to save the race registration.
The race registered appears in the race list alphabetically ordered.
A race can be edited or deleted:

1. Press the race name from the locations list. The selected race is displayed below the
contextual buttons.
2. Press Edit to edit the race or Delete to delete the race from the list.
3.4. To Register a Sample Comment
Follow this procedure to register a sample comment.
Sample comments must be registered to be displayed in the Sample Comment list from the Order
1. Select Sample Comment from the Type dropdown list.

2. Press Add to register a new sample comment.
3. A data field is displayed below the Add button. Type the sample comment (32 alphanumeric
characters max.).
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4. Press Save to save the sample comment registration.

The sample comment registered appears in the sample comment list alphabetically ordered.
A sample comment can be edited or deleted:

1. Press the sample comment from the sample comment list. The selected sample
comment is displayed below the contextual buttons.
2. Press Edit to edit the sample comment or Delete to delete the sample comment from
the list.
3.5. Patient Registration
3.5.1. To Register a Patient
Follow this procedure to register patient information.
Access: Main menu > Order > Patient (tab)
1. Press on an empty line in the PID list.

2. Enter information about the patient.
3. Press Save to register the new patient.
A patient can be edited or deleted:

1. Press on the corresponding PID in the PID list. Details for the selected patient are
displayed.
2. Modify information about the patient or press Delete to delete the patient.
See also:
■ Patient Information, p.151
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3.5.2. Patient Information
The Patient screen allows to register patient information.

Access: Main menu > Order > Patient (tab)
The Patient screen displays the number of patients registered (7000 patients max.), a list of patients
and details for the selected patient. To select a patient press on the corresponding PID in the PID list.
The following details are available for each patient:
Legend Description
PID Patient ID (20 alphanumeric characters max.).
Last Name Patient last name (18 alphanumeric characters max.).
First Name Patient first name (18 alphanumeric characters max.).
Middle Name Patient middle name (18 alphanumeric characters max.).
Social Security # Patient social security number (13 alphanumeric characters max.).
Date of Birth / Age The date of birth of the patient is only available when the Disable button is not
selected. The age is automatically calculated according to the date of birth
registered.
Sex The sex of the patient (Male, Female, NA).
Race The race of the patient. The race is selected from the races already registered
from the Define screen ( Main menu > Services > System Configuration >
Define (tab) ).
Comments Comments (40 alphanumeric characters max.).
From the main screen, patients details are displayed in a pop-up for each sample when pressing on a
sample.
See also:
■ To Register a Race, p.149
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3.6. To Configure Patient Range
Follow this procedure to configure patient generation ranges.
Access: Main menu > Services > System Configuration > Range (tab)
Patient generation ranges can be configured with up to 50 different ranges. Six ranges are already
defined and cannot be changed.
1 = Range name list
2 = Edition field
1. Press on a blank line of your choice in the Range Name list to register a new range.
An edition field is displayed below the range list.
2. Type the name of the range to add (10 alphanumeric characters max.) in the edition field.
3. Press Save to register the new range.
A range can be edited or deleted:

1. Press the range name from the range list.
2. Edit or delete the text.
See also:
■ To Configure Age Range, p.153
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3.7. To Configure Age Range
Follow this procedure to configure the age of patient generation ranges.
Access: Main menu > Services > System Configuration > Setup2 (tab)
Only level 2 users (L2) have access to the generation age range configuration.
Patient ranges defined by default in the Range tab are flagged with Chi, Adu and Sen, corresponding
to the patient age. The age limit of the three age ranges can be defined in the Generation area.
1. Type the age limit between children (Chi) and adults (Adu) generation and between adults (Adu)
and seniors (Sen) generations (from 1 to 99).
2. Press Save to register the new age limits for the generations.
See also:
■ To Configure Patient Range, p.152
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3.8. Sample Identification Code
The sample identification code table allows to identify the SID automatically generated by the instrument.
■ The SID of each sample depends on the type of sample and the SID specified by the user. The SID
is displayed in the worklist from the Order screen.
■ The general identification code corresponds to the SID with a suffix added depending on the
number of measurements performed on that specific sample. The general identification code is
displayed in the Run screen and the Result screen.
General
Sample Type SID Digit number Description
identification code
Normal xxxxxxxxxxxx: Sample identification
xxxxxxxxxxxx 3 - 12 xxxxxxxxxxxx
sample code
Emergency
99000xxx 8 99000xxx xxx: Sample identification code
sample
Control xx: Sample identification code
970000xx 8 970000xxnn1
sample nn: Number of measurement
xxxxx: Reagent code
Standard y: Calibration point (S1, S2, ...,Sn)
98xxxxxy 8 98xxxxxynnm
m: Number of repetition
x: Set number
Multi-standard y: Calibration point (S1, S2, ...,Sn)
950000xy 8 950000xynnm
xxxxx: Reagent code
Serial dilution
y: Calibration point (S1, S2, ...,Sn)
standard 93xxxxx0 8 93xxxxxynnm
nn: Number of measurement
sample
Replicate xx: Sample identification code
9400xx01 8 9400xx01nn1
ISE Standard 960000xx 8 960000xx111 xx: Sample identification code
ISE Cleaning 960001xx 8 960001xx111 xx: Sample identification code
ISE Cleaning-2 960003xx 8 960003xx111 xx: Sample identification code
ISE Activation 960004xx 8 960004xx111 xx: Sample identification code
x: Sample identification code
Blank sample 9510000x 8 9510000xnnm nn: Number of measurement
xxxxx: Reagent code
Reagent blank 91xxxxx1 8 91xxxxx1nnm nn: Number of measurement
Water blank 000000XX 8 000000XX XX : Cuvette number
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4. Application Configuration
4.1. Reagent Registration
4.1.1. To Register Reagents
Follow this procedure to check and to manage reagents, diluents and cleaners registration.
Access: Main menu > Services > System configuration > Reagent (tab)
The Reagent tab displays a list of the registered reagents (1) and the cassette information (2) for each
of them.
1 = List of
registered
reagents
2 = Cassette
information
Reagents and their cassette information must be registered in this screen before loading and using a
reagent cassette on the instrument.
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Only L2 users are allowed to register reagents.
1. Check that the reagent is not already registered before registering a new reagent on the
instrument:
a. Check the list of reagent names for the reagents you intend to use.
b. If the reagent is already registered, select it from the list by pressing on it or by typing its
reagent code in the cassette information area.
The cassette information concerning this reagent is displayed in the cassette information area.
c. Check that information is correct concerning the reagent cassette, the reagent type and the
volumes.
If the reagent has incorrect information, it can be edited or deleted.
If a reagent, a cleaner or a diluent is not found in the list of registered reagents, user must add it
manually.
2. Type a new reagent code in the Reagent Code field (three numerical characters) to add a reagent.
Five reagent codes are available to be used by users for open channels (from 901 to 905). Please
refer to the Code's Method Table chapter to check reagent and application registration for open
channel (see Settings > Application Configuration > Code's Method Table chapter).
3. Type a new reagent name in the Reagent Name area (six alphanumerical characters max.).
4. Select the corresponding cassette from the Reagent Cassette dropdown list.
Open barcode are working only on open cassette type 30/10. Other selectable choices
are not functional for open cassette barcode.
100 mL Single compartment cassette of 100 mL.

30/10 mL Twin compartment cassette of 30 mL (out) and 10 mL (in).
5. Select the reagent type from the Reagent Type dropdown list.
Reagent Type Description

R1 Reagent 1 for single reagent method.
R1&R2 Reagent 1 and reagent 2 for two reagents method.
Wash Cleaner.
Dil. Diluent.
6. If the volume of reagent is different from the one chosen from the Reagent Cassette dropdown
list, type in the corresponding volume in the Vol(out) or Vol(in) field.
The volume displayed is the initial volume of the cassette.
7. Select the Stability Check Enable check box to activate the stability check and type the stability
term in days (two numerical characters max.).
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The initial date for stability check corresponds to the date of first cassette reading.
Reagent cassettes out of date are displayed with red background in the Inventory
screen ( Main menu > Inventory > Inventory ). Results of tests performed with
reagent cassettes out of date are flagged with "STB". To reset the initial date for
stability check when loading a new cassette on the instrument, perform a barcode
scan from the Reagent Tray screen ( Main menu > Inventory > Reagent Tray ).
8. If the reagent is used in the DET.W bottle to clean the probe or the mixer paddle, select the
DET.W Enable check box.
Volume is automatically set to 20 mL and stability term to 14 days.
■ Once registration is saved, the volume of the probe's DET.W bottle can be
checked. Enter Main menu > Services > System Configuration >
Sequences and press DET.W volume Check. The volume of the probe's DET.W
bottle is measured by the liquid level sensor of the probe.
■ The initial date for stability check corresponds to the date of DET.W solution
registration from the Reagent Tray screen ( Main menu > Inventory > Reagent
Tray ).
9. Press Save to save all the settings for the reagent registered.
See also:
4.1.2. To Edit Reagent Information
Follow this procedure to change reagents, cleaners or diluents cassette configuration.
The reagent must be already registered in the list of registered reagents.
1. Choose the reagent you want to edit by one of the following actions:
■ Press on the reagent code displayed in the list of registered reagents.
■ Press on the reagent name displayed in the list of registered reagents.
■ Type the reagent code in the dedicated field in the cassette information area.
Information concerning this reagent are displayed in the cassette information area.
2. Modify data in the corresponding fields.

3. Press Save to save the modifications.
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4.1.3. To Delete Reagent
Follow this procedure to delete reagents, cleaners or diluents.
1. Choose the reagent you want to delete by one of the following actions:
■ Press on the reagent code displayed in the list of registered reagents.
■ Press on the reagent name displayed in the list of registered reagents.
■ Type the reagent code in the dedicated field in the cassette information area.
Information concerning this reagent are displayed in the cassette information area.
2. Press Delete to delete the reagent registration.

4.2. Application Parameters Registration
Application methods can be manually added, imported, edited, deleted or exported.
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4.2.1. To Configure General Application Parameters
Follow this procedure to configure open application parameters.
Access: Main menu > Services > Application Configuration > Applications (tab) > Param 1 (tab)
1 = Method
identification
2 = Photometry
settings
3 = Sample
dispensing
4 = Reagent
dispensing
5 = Operational
conditions
1. Type in the Method field a method number which is not already used (from 56 to 60) to add a new
method.
■ If the method is already used, the parameters of the corresponding method are
displayed.
■ The same method number can be assigned to several sample categories with
different application parameters.
For methods different from HORIBA Medical applications, an available open channel
must be specified. Please refer to the code's method table for method numbers
corresponding to open channels (see Settings > Application Configuration > Code's
Method Table chapter).
2. Type the method name in the Name field (six alphanumerical characters and signs max.). Up to
200 different names can be specified.
3. Type the method version number in the Version field (10 alphanumerical characters and signs
max.).
4. Type the method name used in the printed reports in the Print Name field (15 alphanumerical
characters and signs max.). If the field is left blank, the method name specified in the Name field is
used.
5. Select the sample category from the Sample dropdown list (Common, Serum, Urine, Plasma).
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If several sample categories share the same application parameters, use the common sample
category for them.
6. Type the unit used to display the results (six alphanumerical characters and signs max.) in the Unit
field.
7. Select the assay type from the Assay Type dropdown list (Rate, End).
8. Select the measuring points corresponding to the number of reaction cycles.
Two sets of measuring points are available. To use the second set of measuring points, the
Enable check box must be selected. If selected, the first set is substracted from the second set of
measuring points. A set of measuring points is defined by a start cycle and an end cycle.
■ For End point assay type, the end cycle can be identical or higher to the start cycle.
■ For Rate assay type, the end cycle must be higher than the start cycle.
■ The second set of measuring points must be higher than the first set of measuring points.
A minimum volume of 120 µL is required for measurement.
End point assay type with one measuring point set
End point assay type with two measuring point sets

Result = (mean of set 2) - (mean of set 1)
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Rate assay type with one measuring point set
9. Select the primary wavelength used to monitor the reaction from the Wave Length dropdown list
(340, 405, 510, 546, 570, 600, 660, 700 nm).
10. Select the secondary wavelength used to monitor the background noise or select the Disable
check box to disable the use of a secondary wavelength.
11. Configure the sampling volumes and the dilution factors for normal run and rerun in case of high
values or low values.
1 = Normal run
2 = Rerun because the result is too high
3 = Rerun because the result is too low
a. The dilution factor applied to normal run or rerun can be specified only if the Diluent Enable
check box is selected in the reagent dispensing area.
b. Type sampling volume in the Sampling field (µL). Volume from 2 µL to 45 µL can be specified
with an increment step of 0.1 µL.
c. If the sample has to be diluted, select the Dilution check box and type the dilution factor (from
2.0 to 30,625) with an increment step of 0.1. Dilutions are performed in cuvettes. One cuvette
is used for a dilution factor from 2.0 to 175.0. A serial dilution with two cuvettes is used for a
dilution factor from 175.1 to 30,625.0.
Three different processes are used for the sample dilution depending on the value of the
dilution factor:
■ For dilution factor (Fd) between 2.0 and 7.7: 45 µL of sample are used and the volume of
the diluent used is calculated as follows:
Diluent volume = 45 . (Fd - 1.0)
■ For dilution factor (Fd) between 7.8 and 175.0: the dilution is performed in a final volume of
350 µL. The sample volume and the diluent volume are calculated according to the dilution
factor and the constant final volume:
Sample volume = 350 / Fd
Diluent volume = 350 - (350 / Fd)
■ For dilution factor (Fd) between 175.1 and 30,625.0, the dilution uses of two cuvettes. The
two dilutions are identicals and are calculated according to the following formula:
Fd1-2 = √ Fd
The dilutions are performed in a final volume of 350 µL.
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Sample volume = 350 / Fd1-2

Diluent volume = 350 - (350 / Fd1-2)
d. Specify the rerun volume and the dilution factor of the automatic rerun for the results which are
under or over the technical range. The technical range is specified in concentration or
absorbance in the operational conditions area (5). If no rerun is wanted, type 0 (zero) in the
sampling volume field.
If the sample rerun volume is different from the normal volume, results from normal
and rerun cannot be compared because the final volume is different. In that case,
the rerun result can be corrected using the following formula:
Corrected rerun result = rerun result x (normal volume percentage / rerun volume
percentage) where:
■ Normal volume percentage = (S / (S + R1 + R2))
■ Rerun volume percentage = (SR / (SR + R1 + R2))
S: volume of normal sample
SR: volume of rerun sample
R1: volume of R1
R2: volume of R2
The rerun is only performed on normal samples and emergency samples (STAT).
12. Configure the reagents used in the application and their specifications:
a. Choose the R1 reagent from the Reagent Name dropdown list. The reagent needs to be
already registered to be displayed in the reagent name dropdown list ( Main menu > Services
> System Configuration > Reagent (tab) ).
b. Specify the volume of R1 reagent in µL from 20 µL to 350 µL with an increment step of 1 µL.
c. Specify the volume of water used to push the reagent R1 in µL from 100 µL to 350 µL with an
increment step of 1 µL. Leave the field blank if reagent R1 is not pushed with distilled water.
d. If a R2 reagent is used in the application, select the R2 Enable check box and specify the R2
reagent name, the volume and the volume of water to push the R2 reagent.
13. If sample needs to be diluted for normal run or rerun, select the Diluent Enable check box. Select
the diluent from the dropdown list. To be displayed in the dropdown list, the diluent needs to be
already registered as diluent ( Main menu > Services > System Configuration > Reagent (tab) ).
14. Select the number of digits from the Decimal Points dropdown list to display the concentration
results.
15. Specify the blank to be performed for each measurement:
Blank Description
Disable No blank is performed.
CB Cuvette blank on air.
RB1 Reagent blank with reagent R1.
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A minimum volume of 120 µL is needed for RB1 measurement.
16. Configure the operational conditions:

a. Configure the normal range concentration values for the different patient generation ranges.
Normal range values define the limit values. Flags are displayed when the results are higher or
lower than the min. and max. range values. Press twice to select the range value to define.
Type the min. and max. normal range concentration values for the different patient generation
ranges (from 0 to 9999999). Patient generation ranges are configured in Main menu >
Services > System Configuration > Range (tab) .
■ When measurements results are lower than the min. value, the result is flagged with a "L".
■ When measurements results are higher than the max. value, the result is flagged with a "H".
b. Define the linearity range. The linearity range can be defined in concentration or in absorbance.
If a result is out of the linearity range, the test is automatically rerun with the specified rerun
conditions defined in the sample dispensing area (3).
■ Specify the minimum and maximum concentration values (from 0 to 9999999). Units are
specified in the method identification area.
■ Specify the minimum and maximum absorbance values (from -999999 to 999999) in mAbs/
10.
When out of the linearity range, results are output as the value corresponding to the
linearity range limit concentration and the ">" or "<" sign are added.
c. If a wash of the probe and the mixer paddle is needed before the pipetting of R1 reagent,
select the Probe Wash Enable check box. Choose the washing solution from the Reagent
Name dropdown list and select the reagent type from Reagent Type dropdown list.
d. If the probe needs to be washed after R1 or R2 dispensing, choose the wash solution from
distilled water (Sys. Water) or Wash solution (DET.W). Only an external cleaning of the probe is
performed.
e. Select the stirring speed for mixing the solution after R1 or R2 dispensing.
Stirring speed Description

UH For reagent of extremely high viscosity.
VH For reagent of particularly high viscosity.
High For reagent of high viscosity.
Middle Standard stirring.
Low For reagent of low viscosity.
None No stirring of the reagent.
17. Press Save to save the application parameters registered.
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See also:
■ To Configure Blank Measurement, p.173
■ To Configure Limit Checks, p.169
4.2.2. General Application Management
4.2.2.1. To Copy an Application
Follow this procedure to register an application with the same characteristics of another
application.
1. Select the method to be copied.

2. Select the sample category for this appplication from the Sample dropdown list (Common, Serum,
Urine, Plasma).
3. Select the Copy check box at the bottom of the screen.
4. Type a method number which is not already used in the Method field (from 1 to 60).
For methods different from HORIBA Medical applications, an available open channel
must be specified. Please refer to the code's method table for method numbers
corresponding to open channels (see Settings > Application Configuration > Code's
Method Table chapter).
5. Type a method name in the Name field (six alphanumerical characters and signs max.).
6. Select a sample category from the Sample dropdown list (Common, Serum, Urine, Plasma). If
several sample categories share the same application parameters, use the common sample
category for them.
7. Press Save to register the new method.
A warning is displayed to warn the user to perform a calibration for the new method.
8. Press OK.
9. If necessary, type a new print name in the Print Name field.
10. Change the application parameters for this new application.
11. Press Save.
See also:
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4.2.2.2. To Print an Application
Follow this procedure to print all the parameters from an application. Parameters from the
Param1 screen and the Param2 screen are printed on the same page.
1. Select the application method to print from the Method dropdown list.
2. Select the sample category in the Sample dropdown list.
3. Press more than one second on the green Print button displayed at the bottom of the screen.
All the application parameters including the limits checks, the blank parameters and the correlation
factor displayed in the Param 2 screen are printed on one page.
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4.2.2.3. To Delete an Application
Follow this procedure to delele a method.
The same method number can be assigned to several sample categories. To delete a method, all
sample categories parameters must be deleted.
1. Select the method number to delete from the Method dropdown list.
2. Check the method name registered with the selected method number in the Name dropdown list.
3. Press Delete to delete the method.
5. Check for the presence of the deleted method in the Name dropdown list. If always registered, the
method still exists for another sample category.
6. Select the method name in the Name dropdown list.
7. Press Delete to delete the method.
The method is completely deleted when the name of the method is not displayed in the Name
dropdown list.
4.2.2.4. To Import or To Export an Application
Follow this procedure to import or to export an application.
1. Press on the directory button.
2. Select from the USB key, the target folder for exporting the application or the application folder to
import.
3. Press Open in the pop-up to select the folder.
4. To import an application:
Reagents used in the method to import must be already registered before importation
( Main menu > Services > System Configuration > Reagent (tab) ).
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a. Check that the application to import is not already registered in the instrument.
b. Press Import to import the application.
The application is imported and the method number is blank.
c. Type a method number for this application which is not already used (from 1 to 60).
For methods different from HORIBA Medical applications, an available open

channel must be specified. Please refer to the code's method table for method
numbers corresponding to open channels (see Settings > Application Configuration
> Code's Method Table chapter).
d. Select the imported application name from the Name dropdown list.
e. Press Save to register the imported application.
■ Calibration settings and values are imported with the application.

■ The calibrator name is not imported with the application and must be specified in
the Cal Regist screen ( Main menu > Calibration > Cal Regist (tab) ).
■ Controls settings are not imported with the application and have to be registered by
the user after importation.
5. To export an application:
a. Select a method from the Method dropdown list.
b. Select the sample category from the Sample dropdown list.
c. Press export.
The application is exported in the specified folder on the USB key.
See also:
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4.2.3. Limit Checks and Blank Definition
4.2.3.1. To Configure Limit Checks
Follow this procedure to choose the limits for a method.
1 = Method
selection area
2 = Limit checks
area
3 = Blank
measurement area
4 = Correlation
factor area
1. Select the method number from the Method dropdown list.

The method name is automatically displayed.
3. Select the limit checks to be used with the method from the limits described below.
4. Select the Duplicate Limit check box and type the duplicate limit value in mAbs/10 (from 1 to
99999) to check repeatability of the calibration.
Duplicate Limit: the duplicate limit concerns calibration results. When duplicates or triplicates
measurements are ordered, the duplicate limit is the difference between the lowest and the
highest values for one point.
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1800
1600
Duplicate Limit
1400
1200
OD
Red: DUP flag

1000
Blue: accepted
800
600
400
1 3 5 7 9 11 13 15
Concentration
The flag "DUP" is displayed when the duplicate difference is higher than the specified duplicate
limit value and the calibration value is not updated.
5. Select the Sensitivity Limit check box and type the sensitivity limit value in mAbs/10 (from 1 to
99999) to check the reagent answer during calibration.
Sensitivity Limit: the sensitivity limit concerns the first calibration point and the last calibration
point. The sensitivity limit is the absorbance difference between these two calibration points.
1800
1600
1400
1200
OD
Red: SEN flag

1000
Blue: accepted
800
Sensitivity Limit
600
400
1 3 5 7 9 11 13 15
Concentration
The flag "SEN" is displayed when the absorbance difference is lower than the specified sensitivity
limit value and the calibration value is not updated.
6. Select the Linearity Limit check box and type the linearity limit percentage and the linearity limit
threshold in mAbs/10/min to check the substrate depletion during rate assays.
Linearity Limit: the linearity limit concerns time course for rate assays and allows to check the
linearity between the three first measurement points and the three last points of the kinetic. The
points from each range are used to calculate the slope by regression analysis. The difference
between the two slopes is standardized by the global slope of the kinetic.
Time course results for a test:
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1800
1600 Slope 2
Slope 1 = Slope of the

1400
three first points (linear
regression)
1200
OD
Slope 3 Slope 2 = Slope of the

1000 three last points (linear
regression)
800
Slope 3 = Slope of
points 1 to n-1 (linear
600
Slope 1 regression)
400
1 3 5 7 9 11 13 15
Cycles
The linearity limit is calculated as follows:

Linearity (%) = (|slope1 - slope2| / |slope 3|) . 100 %
The flag "LIN" is displayed when the linearity is higher than the specified limit.
The linearity check is not executed in the following cases:

■ The assay type defined for the method is different than rate.
■ The slope of the time course (slope 3) is lower than the threshold value.
■ The difference between slope 1 and 2 is lower than the threshold value.
■ Less than four measuring points are configured for the method.
■ Sample type is a control.
■ ISE tests.
■ Another error with higher priority occurs (see Alarms > Error Flags chapter for error
rank priority).
7. Select the Prozone Limit check box to check a prozone effect during the reaction. The prozone
limit is the ratio between the slope of two specified ranges of the time course.
1800
1600
1400 SL2
1200
OD
1000
800
SL1
600
400
1 3 5 7 9 11 13 15 Cycles
SL1-S SL1-F SL2-S SL2-F
a. Type the prozone limit percentage (from 0.00001 to 99.99999).

Prozone (%) = (Slope SL2 / Slope SL1) . 100 %
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b. Select from the dropdown list if the prozone limit value specified is the upper limit or the lower
limit.
c. Type the start and final points of the two absorbance ranges to compare:
■ SL1-S: start cycle for slope 1
■ SL1-F: final cycle for slope 1. SL1-F > SL1-S
■ SL2-S: start cycle for slope 2
■ SL2-F: final cycle for slope 2. SL2-F > SL2-S
d. Type the prozone limit threshold in the Sens field in mAbs/10 (from 1 to 999999).
The prozone check is performed if the absorbance value is higher than the threshold value
specified.
The flag "PRO" is displayed when the prozone limit is exceeded.
8. Select the Reaction Limit check box. This check is only used for rate assay type determined on
one measuring point range. It allows you to determine an absorbance limit (primary wavelength)
for a reaction. For reaction trend increasing, the measurement results higher than the reaction limit
specified are not taken into account for the rate calculation. For reaction trend decreasing,
measurement results lower than the reaction limit specified are not taken into account for the rate
calculation.
a. Select the reaction trend (increase / decrease) from the Reaction dropdown list.
b. Type the absorbance limit (from 1 to 999999) in mAbs/10.
1800
1600
1400
1200
OD
1000
800 Absorbance Limit
No flag
600
AB2
AB1
400
1 3 5 7 9 11 Cycles
START END
■ Result without flag is displayed if at least five points are within the absorbance limit. The result
is calculated with those points.
■ The flag "AB2" is displayed when more than one point and less than five points are within the
absorbance limit. The first result is then calculated with those points and a rerun with post-
dilution is performed.
■ The flag "AB1" is displayed when all measuring points exceed the absorbance limit except the
first one. No result is displayed (*****) and a rerun with a post-dilution is performed.
9. Press Save to save the limit checks configuration.
See also:
■ To Configure General Application Parameters, p.159
■ To Configure Blank Measurement, p.173
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4.2.3.2. To Configure Blank Measurement
Follow this procedure to configure blank measurement and calibration adjustment.
The variation of reagent condition influences the concentration calculation. A reagent blank is
performed to prevent the effect of some reagent variation.
1 = Method
selection area
2 = Limit Checks
area
3 = Blank
measurement area
4 = Correlation
Factor area

3. Configure blank measurement method from the Blank measurement dropdown list. S1 is defined
as the first calibration point.
■ Disable reagent blank and S1 blank: the reagent blank and S1 blank are not performed. No
blank is used. The reference point is defined in the application configuration (CB or RB1). S1
and S2 are defined in the calibration settings. If selected, the blank measurement settings are
disabled.
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1800
1600
S2
1400
1200
OD
1000
800
S1
600
0 2 4 6 8 10 12 14
Concentration
■ Enable S1Blank (Factor or Linear): the S1 blank is used during recalibration of linear type
calibration with one point calibration or with factor type calibration. In that case the first
calibration point S1 is used to adjust the intercept of the calibration, keeping the same slope. If
selected, the blank measurement settings are disabled.
1800
1600
1400
1200 Factor K
OD
1000
800
600
S1
0 2 4 6 8 10 12 14
Concentration
■ Enable reagent blank: a full kinetic is performed for the reagent blank. The blank is performed
without sample or with system water instead of the sample. The kinetic blank performed by
this method is deducted from the sample kinetic at each corresponding time point.
1800
1600
S2
1400
1200
OD
1000
800
600
S1
RB
0 2 4 6 8 10 12 14
Concentration
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■ Enable reagent blank for S1 (Linear): the S1 point is not performed and is replaced by the
reagent blank corresponding to the kinetic on the reagent blank. During recalibration of linear
type calibration, the intercept and the slope are adjusted. Recalibration on one point cannot be
ordered.
1800
1600
S2
1400
1200
OD
1000
800
600
RB
0 2 4 6 8 10 12 14
Concentration
4. Select the blank measurement timing from the Measurement of reagent blank during run
dropdown list. This option is enabled only when reagent blank is enabled (kinetic on the reagent
blank).
■ Daily: the reagent blank measurement is performed on a daily basis.
■ Next run: the reagent blank measurement is performed for every run.
■ None: the reagent blank measurement is not performed automatically but only when ordered.
5. Select the sample replacement for the reagent blank from the Reagent blank measurement at
calibration dropdown list. This option is enabled only when reagent blank is enabled.
■ Reagent blank (No sample): only the reagent volume is used for reagent blank measurement.
■ Reagent blank (system water): the reagent blank is performed with the corresponding
reagent volume and the sample volume is replaced by distilled water from the system.
6. Select the replicates number for the reagent blank from the number of measurement dropdown
list (Single, Duplicate, Triplicate). This option is enabled only when reagent blank is enabled
(kinetic on the reagent blank).
7. Select the Duplicate Limit check box and type the absorbance limit in mAbs/10 to perform a
check on the variation of the reagent blank. This option is enabled only when reagent blank is
enabled.
■ The number of reagent blank measurement is defined as duplicate: if both results are within the
limit, the average value of both results is used.
■ The number of reagent blank measurement is defined as triplicate: if all the three
measurements are within the limit, the center value is adopted.
■ The number of reagent blank measurement is defined as triplicate: if one measurement is not
within the limit, the duplicate rule is adopted.
8. Press Save to save the blank configuration.
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See also:
4.2.4. To Configure the Correlation Factor
Follow this procedure to configure the correlation factor for each method.
The correlation factor configuration allows a correction using a linear equation of the results obtained
on the instrument to be consistent with other instruments.
1 = Method
selection area
2 = Limit Checks
area
3 = Blank
measurement area
4 = Correlation
Factor area

3. Configure the slope and intercept for the correlation factor corresponding to the equation y=ax+b
where y is the corrected result, a is the slope, x the result obtained on the instrument and b is the
intercept.
a. Type the slope in the a field.
b. Type the intercept in the b field.
4. Press Save to save the correlation factor configuration.
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4.3. To Configure ISE Parameters
Follow this procedure to configure ISE correlation factor for the different sample
categories (Common, Serum, Urine, Plasma) and the normal range of ISE results.
Access: Main menu > Services > Application Configuration > Applications (tab) > ISE (tab)
1 = Diluent
specification area
2 = ISE Correlation
Factor area
3 = ISE Normal
Range area
2. If the common sample category is chosen, select from the ISE Type dropdown list if the sample is
used undiluted (ISE) or diluted (ISE(D)). ISE is automatically selected if sample category is set to
serum or plasma. ISE(D) is automatically selected if sample category is set to urine.
3. If the ISE sample used is diluted, select the diluent (Standard 1) to use for the dilution from Urine
Diluent Reagent Name dropdown list. The diluent needs to be already registered to be displayed
in the diluent dropdown list ( Main menu > Services > System Configuration > Reagent (tab) ).
4. Define the slope and intercept of the correlation factor for each electrode in the ISE correlation
factor area. The correlation factor configuration allows a correction using a linear equation of the
results obtained on the instrument to be consistent with other instruments.
Correlation factor equation: y=ax+b where y is the corrected result, a is the slope (from -99.99 to
99.99), x the result obtained on the correlation and b is the intercept (from -999.99 to 999.99).
5. Configure the normal range values for the different patient generation ranges. Normal range values
define the limit values and flags are displayed when the results are higher or lower than the min.
and max. range.
a. Press twice to select the range value to define.
b. Type the min. and max. normal range concentration values for the different patient generation
ranges (from 0 to 999.9).
Patient generation ranges are configured in Main menu > Services > System Configuration >
Range (tab) .
■ When measurement results are lower than the min. value, the result is flagged with a "L".
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■ When measurement results are higher than the max. value, the result is flagged with a "H".
6. Press Save to register the ISE parameters.
4.4. To Configure Method to Method Calculation
Follow this procedure to configure the result of a method-to-method calculation (ratio).
Access: Main menu > Services > Application Configuration > Ratio (tab)
1 = Calculation
specification area
2 = Normal Range
area
3 = Calculation
symbols area
4 = List of methods
available
The method-to-method calculation is automatically performed when all the tests in the calculation are
ordered. To easily order all tests necessary for a calculation, a profile can be configured ( Main menu
> Services > Application Configuration > Profiles (tab) ) and will be available from the Order screen
1. Specify a ratio method number in the No. (3001-3040) dropdown list. The ratio method number
already registered are displayed in the dropdown list. To specify a new ratio method, type an
available number from 3001 to 3040 in the No. field.
40 different ratio methods can be configured. If a ratio method is already registered, all the
parameters corresponding to the ratio method are displayed.
2. Type the name of the ratio method in the Name dropdown list (six alphanumerical characters and
signs max.).
3. Type the print name (15 alphanumerical characters and signs max.) in the Print Name field.
If the field is left blank, the name specified in the Name field is used.
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5. Type the unit used to display the results (six alphanumerical characters and signs max.) in the Unit
field.
6. Select the number of digits from the Decimals dropdown list to display the calculated results
(from 0 to 5).
7. Input the calculation method:
a. Press twice on a method from the methods list (4) to select the method.
b. Select from the calculation symbol area (3), the symbol key corresponding to the calculation to
perform.
c. Select another method from the method list or type numbers using the virtual keyboard. Up to
10 methods can be used for the calculation.
8. Configure the normal range values for the different patient generation ranges. Normal range values
define the limit values and flags are displayed when the results are higher or lower than the min.
and max. range.
a. Press twice to select the range value to define.
b. Type the min. and max. normal range concentration values for the different patient generation
ranges (from 0 to 999.9).
Patient generation ranges are configured in Main menu > Services > System Configuration >
Range (tab) .
■ When measurements results are lower than the min. value, the result is flagged with a "L".
■ When measurements results are higher than the max. value, the result is flagged with a "H".
9. Press Save to save the method to method calculation settings.
The ratio is automatically calculated if all the tests used for the calculation are ordered for the same
sample.
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4.5. To Configure a Profile for a Group of Tests
Follow this procedure to register a profile for a group of test.
Access: Main menu > Services > Application Configuration > Profiles (tab)
The profile allows you to group several methods. When a profile is ordered from the Order screen
( Main menu > Order ), all the tests registered in the profile are automatically ordered.
Profiles can be used to select all the tests needed for ratio calculation.
1. Select a profile number from the No. dropdown list (from 1 to 20).
If a profile is already registered for the profile number, it is automatically displayed. If the profile
number is available for a new profile registration, the Name field is blank. Up to 20 different
profiles can be registered.
2. Type the profile name in the Name field (six alphanumerical characters and signs max.)
4. Select all the methods to group in the profile.
All the selected methods are automatically ordered when the profile is ordered.
5. Press Save to register the profile.
The profiles registered are available for selection at the bottom of the Selection screen.
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4.6. To Configure a Mask
Follow this procedure to select tests that will not be performed.
Access: Main menu > Order > Mask (tab)
Three mask types can be selected:
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■ N: mask for normal samples.

■ C: mask for control samples.
■ S: mask for standard samples.
1. Press N, C or S to choose the mask type to configure.
■ The mask types N and S allow to select tests that will not be performed for normal
or standard samples.
■ The mask type C allows to select tests that will not be performed for a specific control.
2. For the mask type C, press Control Name button to select the control.
3. Select the tests (press on the corresponding buttons).
Tests are blue when selected.
4. Press Save to register the mask configuration.
4.7. To Configure the Methods Sequence
Follow this procedure to configure the measurements sequence order and the methods
order on a printout.
Access: Main menu > Services > Application Configuration > Incompatibility (tab) > Order (tab)
The measurement order option is available to configure the order of measurement of the tests for a
sample. In case of incompatibility between two methods, this option allows you to choose to run a
method before another method to prevent incompatibility.
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1. Drag the method to organize the sequence in the Measurement Order area.
The measurements within a run are ordered according to the measurement order specified.
2. Select the Same Order check box to configure the same order for the printout.
3. Unselect the Same Order check box and drag the methods from the Print Order area to
configure a different order for the printout.
4. Press Save to register the methods order for measurement and printout.
4.8. To Program Wash for Incompatibility
Follow this procedure to program extra wash of the probe in case of incompatibility
between reagents.
Access: Main menu > Services > Application Configuration > Incompatibility (tab) > Wash cycles (tab)
In case of incompatibility between reagents that cannot be solved by measurement order, an extra
wash of the probe can be specified between the two reagents.
The extra wash specified in Wash cycles screen is not performed on the mixer.
1 = Methods
specification area
2 = Wash
registration area
3 = Wash
programs list area
1. Select the two methods between which the extra wash must be performed.
a. Select the All check box to select all methods.
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If selected, "*" is displayed in the method field and no name is displayed.
b. Select the method from the Method dropdown list to select a specific method.
The extra wash will be performed when the method2 is performed immediately after method1.
2. Select the washing solution for each possible wash event between method 1 and 2.
■ Sys.Water: distilled water from the water tank.
■ DET.W: wash solution from the DET.W bottle.
■ Wash Bottle: solution from a reagent cassette must be specified with the Reagent Type and
the Reagent Name dropdown list.
3. If Wash Bottle is selected:

a. Select the reagent type from the Reagent Type dropdown list (R1, R2, Wash).
b. Select the reagent to use from the Reagent Name dropdown list.
4. Press Save to save the wash program between the two methods.
A list of registered incompatibilities and wash programs is displayed in the wash programs list area.
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4.9. Calibration Settings
4.9.1. To Configure Calibration
Follow this procedure to configure a calibration for a test.
Access: Main menu > Calibration > Calibration (tab)
1 = Calibration
settings area
2 = Calibration
results area
1. Select the method number concerned by calibration configuration from the Method dropdown list.
2. Select the sample category for calibration configuration from the Sample dropdown list (Common,
Serum, Urine, Plasma).
3. Select the number of replicates for the calibration measurements from the Replicate dropdown
list (Single, Duplicate, Triplicate).
4. Type the validity of the calibration curve in days in the Stability field. If 0 (zero), no check for
calibration validity is performed.
When the validity date of the calibration curve is expired, the test is displayed in red in the Order
If patients or control samples are run without a valid calibration, the results are flagged
with CTO or STM.
5. Select the type of calibration curve from the Mode dropdown list.
Type of curve Description Number of calibration points

Factor The calibration curve is defined by a theoretical factor. 0
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Type of curve Description Number of calibration points

Linear The calibration curve is defined by a linear regression. 2-7
regression
Linear The calibration curve is defined by a linear interpolation from point 2-7
interpolation to point.
Logit-Log The calibration curve is defined by a logarithmic curve. Up to 7
Spline The calibration curve is defined by several polynomial curves. Up to 7
Exponential The calibration is defined by an exponential curve. Up to 7
An extended calibration curve can be used for measurements out of the calibration curve if the
extrapolated results option is enabled in the Setup screen ( Main menu > Services > System
Configuration > Setup (tab) ).
Calculation rules for results out of the calibration curve
Type of curve Concentration range Calculation Concentration value without

extrapolation
Linear Under S1 / Over Sn Extended linear calibration curve. -
regression
Linear Under S1 / Over Sn Extended linear curve between S1 / Sn
interpolation the two first (under S1) or the two
last (over Sn) calibration points.
Logit-Log Under S1 / Over Sn Extended tangent line of the S1 if S1 = 0 / -
concerned point.
Spline Under S1 / Over Sn Extended tangent line of the S1 / Sn
concerned point.
Exponential Under S1 / Over Sn Extended tangent line of the S1 if S1 = 0 / -
concerned point.
6. Select the calibration lot from the Lot dropdown list (New, Old).
Two calibration curves are available depending on the reagent lot number.
7. Type the calibrator name in the Cal. Name field (eight alphanumerical characters max.).
This field is not available for factor calibration.
8. Type the concentration values (from 0 to 9999999) for each calibration point starting with the lower
value (S1).
These fields are not available for factor calibration.
9. Type the calibrator lot number in the Lot# field for each calibration point. If all calibration points
share the same calibrator lot number, select the All check box.
Actual and Master fields display the measurement results for the calibration. Master corresponds
to full calibration, whereas actual corresponds to partial calibration (one or two points). The actual
calibration is the calibration used for control and sample concentration calculation.
10. If factor calibration has been selected for the calibration Mode, type the factor in the K field (10
alphanumerical characters max.).
11. Verify the specification for the calibration blank which has been registered in the application.
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The use of S1 or reagent as blank is available for factor calibration or linear calibration. The blank
selected in the application settings is displayed as S1 Blank (factor or linear calibration type) or
Reagent Blank for S1 (linear calibration type). These settings are available to be modified in Main
menu > Services > Application Configuration > Applications (tab) > Param 2 (tab) . A detailed
description of the blank choice is available in the application parameters chapter (see Settings >
Application Configuration > Application Parameters Registration > To Configure Limits and Blank
Parameters chapter).
The last calibration results are available in the calibration results area:
■ The reagent lot number is displayed for R1 and R2 reagents as well as the last calibration date
which is displayed in the Last field.
■ The graph displays the actual calibration curve in blue and the master calibration curve in red.
■ The last reagent blank result is displayed as well as its execution date.
■ The last blank result is displayed as well as its execution date.
A tool is available for concentration calculation using either the actual calibration or the master
calibration. To use it, select the type of calibration from the Mode dropdown list. Type the absorbance
in mAbs/10 and press Recalculation. The calculation result is displayed in the Conc field.
See also:
■ To Register a Serial Dilution, p.187
■ To Select Methods Associated with a Multi Standard, p.189
4.9.2. To Register a Serial Dilution
Follow this procedure to configure a serial dilution for calibration.
Access: Main menu > Calibration > Reg SerialDilut (tab)
The different calibrator concentrations must be registered before in the Calibration screen.
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1. Select the method number in the Method dropdown list and the sample category in the Sample
dropdown list.
Method name, unit, calibrator lot number and concentrations are automatically displayed.
If using different calibrator lot numbers, only the lot number corresponding to the
higher concentration is displayed.
The concentration value displayed is the value of the original calibrator. If a dilution of
the sample is specified in the application method, the dilution is also applied to the
calibrator.
2. For each concentration, the dilution rate is automatically calculated using the highest
concentration of calibrator registered. Check that no dilution rate is displayed in red (incorrect
dilution rate). If a dilution rate is displayed in red, check again the concentration value registered
and the dilution rate.
Dilutions are performed in cuvettes. One cuvette is used for a dilution factor from 2.0 to 175.0. A
serial dilution with two cuvettes is used for a dilution factor from 175.1 to 30,625.0.
3. Press Save to save serial dilution registration.
Three different processes are used for the sample dilution depending on the value of the dilution factor:
■ For dilution factor (Fd) between 2.0 and 7.7: 45 µL of sample are used and the volume of the
diluent used is calculated as follows:
Diluent volume = 45 . (Fd - 1.0)
■ For dilution factor (Fd) between 7.8 and 175.0: the dilution is performed in a final volume of 350 µL.
The sample volume and the diluent volume are calculated according to the dilution factor and the
constant final volume:
Sample volume = 350 / Fd
Diluent volume = 350 - (350 / Fd)
■ For dilution factor (Fd) between 175.1 and 30,625.0, the dilution uses of two cuvettes. The two
dilutions are identicals and are calculated according to the following formula:
Fd1-2 = √ Fd
The dilutions are performed in a final volume of 350 µL.
Sample volume = 350 / Fd1-2
Diluent volume = 350 - (350 / Fd1-2)
See also:
■ To Configure Calibration, p.185
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4.9.3. To Select Methods Associated with a Multi Standard
Follow this procedure to define the methods using the same multi standard. The calibrator
name will be automatically displayed when the method is selected for calibration
configuration.
Access: Main menu > Calibration > Cal Regist (tab)
1. Select an available set number from the Set No. dropdown list.
2. Type the multi standard name (six alphanumerical characters max.) in the Name field.
The methods defined for this sample category are automatically displayed. If the method you want
to select is not displayed, refer to the application parameters registration chapter to configure the
method for the sample category (see Settings > Application Configuration > Application
Parameters Registration > To Configure General Application Parameters chapter).
4. Select the methods to associate with the multi standard set by selecting the corresponding check
box.
5. Press Save to save the new multi standard set.
■ To unselect methods associated with the multi standard set, select the set number and
unselect the methods to be removed. Press Save to save the new configuration.
■ To delete a multi standard set, select the set number, delete the set name and
unselect all the methods. Press Save to delete the multi standard set.
See also:
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4.10. Control Settings
4.10.1. To Register a New Control
4.10.1.1. To Add a New Control
Follow this procedure to add a new control to the registered controls.
Access: Main menu > Calibration > QC Registration (tab)
1 = Control ID area
2 = Registered
Controls list area
3 = Methods area
1. Check the registered controls list and identify an available control ID.
2. Select the control ID number from the Control ID C dropdown list or type the corresponding
number (from 1 to 40).
3. Type the name of the control in the Name field (20 alphanumerical characters max.).
4. Select the sample category corresponding to the control from the Sample dropdown list
(Common, Serum, Urine, Plasma).
5. Type the control lot number in the Lot No. field (six alphanumerical characters max.).
The methods area should be empty when registering new control. Methods associated with each
control are defined in the QC Setting screen ( Main menu > Calibration > QC Setting (tab) ).
6. Press Save to register the new control.
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4.10.1.2. To Define Control Parameters for a Method
Follow this procedure to link a method with a control and to define control values and
flags rules.
Access: Main menu > Calibration > QC Setting (tab)
1 = Control ID area
2 = Control
specification area
3 = Flags Rules
area
4 = Registered
Controls list
1. Select the method for control configuration from the Method dropdown list.
The method name is automatically displayed in the Name field.
2. Select the sample category corresponding to the control to register from the Sample dropdown
list (Common, Serum, Urine, Plasma).
If controls are already registered for this method and this sample category, they are displayed in
the control specification area.
3. Type the control validity (minutes) in the Interval field. If 0 (zero), no check for control validity is
performed. If the control validity has expired, the test is displayed in yellow.
4. Specify the mean used as reference for the confidence range from the Mode dropdown list.
■ Mean-R: the mean value specified for the control is used as reference. If selected, the No. field
is inactive and you must register the mean and the SD specified for each control.
■ X-R: the mean is calculated from the results obtained on the latest control results. The number
of control results used for mean calculation must be specified in the No. field.
The mean value defines the X-axis position in the quality control graph ( Main menu >
QC > Graph (tab) ).
5. Type the number of control results to use for mean calculation. Only available if X-R mode is
selected in the Mode field.
6. Select the Control from the Control Name dropdown list.
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Only controls registered in the QC Registration screen for the selected sample category are
displayed in the dropdown list.
7. Type the mean value and SD value (seven numerical characters max. for mean and from 0.001 to
999.999 for SD).
They are specified for each control as the target value and the 1 SD value in the annex of the
control notice. Mean value registration is only available if Mean-R mode is selected in the Mode field.
The unit used for the method is specified in Main menu > Services > Application
Configuration > Applications (tab) > Param 1 (tab) . Values registered for the control
must have the same unit.
8. Select the error flags and warning flags rules. A dropdown list allows to display or not a flag for
each rule with an error or a warning.
Field Description Code

1 Current result exceeds 2SD. 1:2S
4 The two last results exceed 2SD. 2:2S
5 Two out of the three last results exceed 2SD. 2/3:2S
6 The difference between the two last results exceeds 4SD. R:4S
7 The three last results exceed 1 SD within the term. 3:1S
8 The four last results exceed 1 SD within the term. 4:1S
The 10 last results are greater than the mean. 10:X[+]
9
The 10 last results are smaller than the mean. 10:X[-]
The last results are likely to increase in seven consecutive points. 7:X[+]
10
The last results are likely to decrease in seven consecutive points. 7:X[-]
See also:
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4.10.2. To Change Control Lot Number and Target Values
Follow this procedure to register the new target values when using a new control lot.
Access: Main menu > Calibration > QC Registration (tab)
1. Check the registered controls list to identify the control ID of the control to update.
2. Select the control ID number of the control to display from the Control ID C dropdown list.
3. Type the new lot number of the control in the Lot No. field.
4. Press Save to register the new lot number for the control.
5. Select the QC setting tab to define the new target value and new SD value for each method using
the control.
The method name is automatically displayed in the Name field.
8. Type the new mean value and the new SD value (seven numerical characters max. for mean and
from 0.001 to 999.999 for SD).
They are specified for each control as the target value and the 1 SD value in the annex of the
control notice. Mean value registration is only available if Mean-R mode is selected in the Mode field.
The unit used for the method is specified in Main menu > Services > Application
Configuration > Applications (tab) > Param 1 (tab) . Values registered for the control
must have the same unit.
9. Press Save to save the target values for the control.

10. Change target values for each method using the concerned control. A list of method using the
control is available in the QC Registration tab.
4.11. Code's Method Table
Refer to the following table for reagents and methods registration.
Open channels (default settings)
Name Category Application N° Reagent Code Reagent Type Cassette Volume R1/R2
Type Type
OPEN1 Common 56 901 R1 30/10 30/10
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Type Type
OPEN2 Common 57 902 R1&R2 30/10 30/10
OPEN3 Common 58 903 R1&R2 30/10 30/10
OPEN4 Common 59 904 R1&R2 30/10 30/10
OPEN5 Common 60 905 R1&R2 30/10 30/10
Only level 2 users (L2) are allowed to perform this action.
Diluents
Type Type
H2Od open cassette 801 out 810 dil 30/10 30/10
Std1 open cassette 801 in 811 dil 30/10 30/10
Phy NA 812 dil 30/10 30/10
SDIL NA 057 dil 100 99
Acc1 NA 061 R1 100 99
Acc2 NA 062 R1 100 99
Wash
Type Type
Deprot NA 060 wash 100 30
Etching NA 051 wash 100 25
CleanC NA 059 wash 100 30
Wash NA 850 wash NA NA
Precision tests
Type Type
T1 Common 1 701 R1 30/10 30/10
Sdye Common 590 700 R1 30/10 30/10
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1. Maintenance..........................................................................................................................196
1.1. Daily Procedures.....................................................................................................................198
1.2. Weekly Procedures.................................................................................................................201
1.3. Monthly Procedures................................................................................................................213
1.4. Yearly Procedures...................................................................................................................219
1.5. Other Procedures....................................................................................................................222
1.6. Customer Services..................................................................................................................244
1.7. Maintenance Schedule...........................................................................................................251
2. Troubleshooting...................................................................................................................252
2.1. Operation Problems................................................................................................................252
2.2. Analysis Cycle Problems.........................................................................................................253
2.3. Result Problems......................................................................................................................259
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1. Maintenance
Daily Procedures
Unit Frequency Action Tools and consumables

ISE electrodes day if >20 Clean 2 Etching solution (ABX Pentra Etching CP
tests per day A11A01769).
Perform the ISE cleaning every week if running
less than 20 samples per day.
Sample and Reagent day Dry Gauze or paper towel.
Container Unit
Probe day Clean Deproteinization solution (ABX Pentra
Weekly Procedures

ISE solutions week Check Phillips® screwdriver.
ISE electrodes week Clean 1 Deproteinization solution (ABX Pentra
Deproteinizer CP A11A01754), dummy electrode
(ABX Pentra Dummy Electrode A11A01851),
cleaning kit for chloride electrode (Cleaning kit
for ABX Pentra Chloride-E XEA935AS), Phillips®
screwdriver.
ISE electrodes week Clean 2 Etching solution (ABX Pentra Etching CP
A11A01769).
Sample and Reagent week Dry Gauze or paper towel.
Container Unit
Probe (external) week Clean Gauze, 70% ethanol.
DET.W week Change Wash solution (ABX Pentra Clean-Chem CP
A11A01755).
Probe week Clean Deproteinization solution (ABX Pentra
Tubing and tanks 2 weeks Clean Water, diluted bleach solution.
Monthly Procedures

ISE solutions 1 month Replace Standard 1 (ABX Pentra Standard 1 A11A01717)
and Reference (ABX Pentra Reference
A11A01719) solutions.
Precision Test 1 (T1) 1 month Check Qualitest solution (ABX Pentra Qualitest
Solution A11A01758), open cassette 30/10.
Wash syringe plunger tip 3 months Replace Paper towel, syringe tip insertion tool, 3 mm
hexagonal key, Phillips® screwdriver, pliers,
syringe tip (WPP syringe tip (x10) F10B05511),
silicon oil (Oil silicon tips XEC086AS).
Reagent syringe plunger tip 3 months Replace Paper towel, syringe tip insertion tool, 3 mm
syringe tip (RPP syringe tip (x10) F10B05508),
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Sample syringe plunger tip 6 months Replace Paper towel, syringe tip insertion tool, 3 mm
syringe tip (SPP syringe tip (x10) F10B26109),
Filter 6 months Replace Filter (Fluid, Inline Filter F10B40253). Perform
this procedure during tubings and tanks cleaning.
Yearly Procedures

Probe year Replace Paper towel, probe (Probe F10B40255),
hexagonal key.
Other Procedures

Cl- ISE electrodes As needed Replace Cl- ISE electrodes (ABX Pentra Chloride-E
(4 months) A11A01739), Phillips® screwdriver.
K+ ISE electrodes As needed Replace K+ ISE electrodes (ABX Pentra Potassium-E
(6 months) A11A01740), Phillips® screwdriver.
Na+ ISE electrodes As needed Replace Na+ ISE electrodes (ABX Pentra Sodium-E
(1 year) A11A01738), Phillips® screwdriver, Etching
cassette (ABX Pentra Etching CP A11A01769),
pipette (10 µL) and yellow tip.
Ref ISE electrodes As needed Replace Ref ISE electrodes (ABX Pentra Reference-E
(1 year) A11A01741).
Dust pod As needed Replace Dust bag, waste bag inserting tool, rubber band.
Covers As needed Clean Gauze or paper towel, disinfectant product*.
Probe As needed Unblock Gauze, 70% ethanol, cleaning jig (Probe
Cleaning Jig F10B05964), deproteinization
solution (ABX Pentra Deproteinizer CP
A11A01754).
Lamp As needed Replace Lamp, Phillips® screwdriver.
Instrument As needed Decontamination Gauze or paper towel, disinfectant product*.
Instrument As needed Extended Switch Water, diluted bleach solution.
Off
Instrument As needed Switch On Water.
* Disinfectant product must have the following microbiological properties:

■ Bactericidal
■ Fungicidal
■ Active on Aspergillus fumigatus
■ Active on Mycobacterium tuberculosis (BK)
■ Antiviral (VIH, HBV and rotavirus)
Product example validated by HORIBA Medical:

ANIOS detergent disinfectant (WIP’ANIOS 1316.424).
Additional six-month and yearly maintenances need to be performed by an

HORIBA Medical authorized engineer for instrument accuracy and reliability.
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1.1. Daily Procedures
1.1.1. To Clean ISE with Etching (Option)
the week.
1.1.1.1. To Load Etching Solution on the Sample Tray

A11A01769).

a tube.
1.1.1.2. To Perform the ISE Cleaning

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1.1.1.3. To Perform an ISE Activation
exchange.

1.1.2. To Clean Sample and Reagent Container Unit
Follow this procedure to clean and to remove condensed water in the Sample and
Reagent Container Unit (SRCU) after every day of work on the instrument.

■ Tools and consumables used during this procedure: gauze or paper towel.
After instrument use, the SRCU contains condensed water. A daily cleaning procedure must be
followed to ensure accurate reading of the barcode reader.
1. Remove the SRCU cover.

2. Remove the sample and reagent trays.
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3. Wipe the SRCU surface (edge and bottom) with a gauze or a paper towel to remove all drops.
4. Put the sample and reagent trays back.
5. Put the SRCU cover back.
1.1.3. To Clean the Probe with Deproteinizer

See also:
■ Sequence, p.244
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1.2. Weekly Procedures
Perform the procedures every week at the end of a day of work. Perform the maintenance
procedures according to the organization suggested below.
1.2.1. To Check ISE Solutions (Option)
If an ISE module is installed, follow this procedure to check ISE solutions and change
them if necessary.
Access: Main menu > Services > Customer Services > WorkHour (tab)
1. Check the remaining volume for ISE solutions in Services > Customer Services > WorkHour
(tab) .
If the volume is lower than 28 mL for Standard 1 solution or 10 mL for Reference solution or if the
solution is on board for more than one month, the bottle needs to be replaced.
2. If one of the bottles needs to be replaced, open the ISE solution compartment to replace it. See
Maintenance and Troubleshooting > Maintenance > Monthly Procedures > To Change ISE
Solutions chapter.
R: Reference solution
L: Standard 1 solution
3. If one of the bottles is changed, reset its volume in Services > Customer Services > WorkHour
(tab) . Press Reset for L solution (Standard 1) or Ref solution (Reference).
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Only level 2 users (L2) are allowed to reset the solution volumes.

5. If bottles are changed, tubing must be refilled with new solutions. Perform an ISE Prime from the
Sequence tab ( Services > Customer Services > Sequence (tab) ):
a. Type 5 on the right of the ISE Prime button to run five primes.
b. Press ISE Prime.
c. Wait until the end of the primes: instrument status changes from "ANALYSING" to "READY".
■ ISE reagents running dry can damage the electrodes.

■ In order to minimize environment interferences, the ISE module cover must always
be closed during the ISE module operation.
1 = ISE module cover
2 = STAT module cover
See also:
■ To Change ISE Solutions, p.213
■ Sequence, p.244
■ Work Hours, p.248
1.2.2. To Clean ISE with Deproteinizer
Follow this procedure to ensure removal of protein residues from the tubing and
electrodes. Perform the ISE module cleaning procedure on a weekly basis.
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Deproteinizer CP A11A01754), dummy electrode (ABX Pentra Dummy Electrode A11A01851),
cleaning kit for chloride electrode (Cleaning kit for ABX Pentra Chloride-E XEA935AS), Phillips®
screwdriver.

2. Check the remaining volume for ISE solutions in Services > Customer Services > WorkHour
(tab) .
If the volume is lower than 28 mL for Standard 1 solution or 10 mL for Reference solution, the
bottle needs to be replaced.
3. If one of the bottles needs to be replaced, open the ISE solution compartment to replace it. See
Maintenance and Troubleshooting > Maintenance > Monthly Procedures > To Change ISE
Solutions chapter.
5. Pour 2 mL of Deproteinizer solution from an Deproteinizer cassette (ABX Pentra Deproteinizer
CP A11A01754) into a tube.
6. Place the Deproteinizer tube at position 15 in the sample tray.
7. Close the SRCU cover and the main cover.
8. Open the Selection screen.
9. Select position 15.
10. Select ISE Cleaning from the Type dropdown list.
12. Remove the ISE cover on the left-hand side of the instrument by unscrewing the two screws.
13. Open the ISE module cover by loosening the fixing screw.
14. Replace the chloride electrode by the Dummy electrode (ABX Pentra Dummy Electrode
A11A01851).
15. Tighten the ISE module screw.
16. In Sequence screen ( Main menu > Services > Customer Services > Sequence (tab) ), press
ISE Cleaning.
The instrument status change from "READY" to "ANALYSING".
17. Clean the chloride electrode as follows:

a. Use the thread provided in the Cleaning kit (Cleaning kit for ABX Pentra Chloride-E
XEA935AS) for the Chloride-E.
b. Pull one thread one time slowly and carefully through the sample channel of the electrode.
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Do not wash and re-use the threads. They are designed for single use only.
c. Check that the O-ring is well-positioned on one side of the electrode.
18. Wait until the cleaning cycle is finished: instrument status switches back to "READY" (seven to
eight minutes) and replace the Dummy electrode with the chloride electrode.
19. Close the ISE cover.
20. Remove the deproteinizer tube from the sample tray.
22. Refill the tubing with new solutions:

a. Open the Sequence screen ( Services > Customer Services > Sequence (tab) ).
b. Type 1 on the right of the ISE Prime button.
c. Press Prime.
Wait until the end of the prime: instrument status changes from "ANALYSING" to "READY".
Perform ISE calibration and run controls to check the electrodes. See Workflow > Calibration and
Control > To Calibrate ISE chapter.
See also:
■ Sequence, p.244
■ To Calibrate ISE, p.97
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1.2.3. To Clean ISE with Etching
the week.
1.2.3.1. To Load Etching Solution on the Sample Tray

A11A01769).

a tube.
1.2.3.2. To Perform the ISE Cleaning

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exchange.

See also:
1.2.4. To Clean Sample and Reagent Container Unit
Follow this procedure to clean and to remove condensed water in the Sample and
Reagent Container Unit (SRCU) after every day of work on the instrument.

■ Tools and consumables used during this procedure: gauze or paper towel.
After instrument use, the SRCU contains condensed water. A daily cleaning procedure must be
followed to ensure accurate reading of the barcode reader.
1. Remove the SRCU cover.

2. Remove the sample and reagent trays.
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3. Wipe the SRCU surface (edge and bottom) with a gauze or a paper towel to remove all drops.
4. Put the sample and reagent trays back.
5. Put the SRCU cover back.
1.2.5. To Change Wash Solution (DET.W)
Follow this procedure to change DET.W bottle's solution.

■ Tools and consumables used during this procedure: Wash solution (ABX Pentra Clean-Chem CP
A11A01755).
Two DET.W bottles are available. One close to the mixer and one close to the probe. DET.W bottles
are used for programmed wash of these two units during measurement. Wash solution used in DET.W
is the Clean-Chem (ABX Pentra Clean-Chem CP A11A01755) solution available in cassette.
1 = DET.W bottle for mixer
2 = DET.W bottle for probe
2. Press Mix Ascend.
Wait until the end of the cycle: the Mix Descend button is accessible.

4. Rotate manually the mixer arm to the right.
5. Remove the two DET.W bottles and empty the solution by inverting them (a hole in the corner
allows easy emptying). Clean them with distilled water and fill them with approximately 10 mL of
Wash solution (ABX Pentra Clean-Chem CP A11A01755) from a cassette.
6. Place the DET.W bottles back to their dedicated locations as indicated by the arrow.
7. Press on the bottle to make sure that it is fully and uniformly set in place.
9. Press Mix Descend.
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Wait until the end of the cycle: instrument status is "READY".
10. Open the Reagent Tray screen ( Main menu > Inventory > Reagent Tray (tab) ).
11. Select the mixer's DET.W.
12. Press Delete.
14. Press Reagent selection to register the new wash solution.

15. Select Wash from the reagent list displayed.
16. Press OK.
17. Press Save to save the new wash solution registration.
18. Select the probe's DET.W.
19. Repeat step 12 to 17 to delete and register the new wash solution for the probe's DET.W bottle.
1.2.6. To Switch Off the Instrument for Maintenance Procedures
Follow this procedure to switch off the instrument during maintenance.
To shutdown an instrument with ISE electrodes on board for more than three hours
perform the extended shutdown procedure (see Maintenance > Other Procedures > To
Perform an Extended Shutdown with ISE chapter). Damage to the electrodes and the
reagents may occur if the instrument is off for more than three hours.
1. From the main screen press the Shutdown button in the generic toolbar at the top of the screen.
2. Press Power Off.

The pop-up is displayed and the window becomes black when the shutdown cycle is finished.
3. Wait until then to switch off the instrument by pressing the power switch, on the right-hand side of
the instrument.
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1.2.7. To Perform Weekly Probe Cleaning (External)
Follow this procedure to clean the probe after a week of work on the instrument.
■ The instrument must be switched off.

■ Tools and consumables used during this procedure: gauze, ethanol.
Ethanol is used during this procedure. Do not handle ethanol close to fire or high
temperature parts/units.
1. Lift up the probe unit by hand.

2. Wipe the probe gently from top to bottom with a gauze moistened with ethanol.
■ Gentle handling is recommended. Avoid bending the probe arm or the probe while
cleaning.
■ Never wipe the probe from bottom to top as it may damage the probe and/or insert
gauze fragments into the probe.
3. Wipe the probe gently from top to bottom with a gauze moistened with distilled water.
4. Dry the probe with soft cloth.
5. Return the probe arm to the wash tower position.
1.2.8. To Switch On the Instrument
Follow this procedure to switch on the instrument.
■ Check that the probe and the mixer paddle have no obstacle on their way.
■ Check that the cuvettes racks and the dust pod are perfectly positioned.
■ Check that the main cover is closed.
■ If running an analyzer connected to an ISE module, check that the electrodes are installed and
solutions connected.
1. Switch on the instrument by pressing the power switch on the right-hand side of the instrument.
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After a few seconds, "Processing initial communication setup" message is displayed.

At the end, the pop-up disappears and a new message concerning ISE module (option) is displayed.
2. If the ISE module is ready, press OK.

A pop-up warns the user that preparatory mode of operation is executed.
3. Press OK.
As soon as the instrument initialization is complete, the Login/Logout window is accessible.
1 = User name
2 = Password
3 = Login button
4 = Logout button
4. Press the arrow from the users dropdown list to display users.
5. Select the user.
6. Type your password in the password field.
7. Press Login.
A pop-up is displayed for user confirmation.
8. Press OK.
9. Press the Back button in the generic toolbar to enter the main screen.
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1.2.9. To Clean the Probe with Deproteinizer

See also:
■ Sequence, p.244
1.2.10. To Perform Tubing and External Tanks Decontamination
Follow this procedure to clean external tanks and tubing every two weeks in order to
protect tubing and tanks against microorganisms growth. Perform this procedure before
probe cleaning with deproteinizer.
Access: Main menu > Services > Customer Services > Sequence (tab)

■ Tools and consumables used during this procedure: water, diluted bleach solution.
1. Empty the water tank and the waste tank.
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2. Use the water tank to prepare 5 L of wash solution.

Wash solution is a 9.6% concentrated bleach solution diluted 10 X.
3. Put back respective tubings in the waste tank and the water tank.
4. Place the tanks in their dedicated positions.
5. From the Sequence tab press the Tubing Wash button.
Tubing is filled with washing solution and a 10-minute incubation is performed for effective
decontamination. When decontamination is complete, a pop-up is displayed.
6. Remove the remaining solution from the water tank.

7. Fill the water tank with distilled water.
8. Press OK to wash the tubing with distilled water.
9. Remove remaining water from the water tank and fill it with distilled water.
10. Prime to fill the system with distilled water:
a. Type 6 for the number of primes.
b. Press the Prime button.
11. If necessary (every six months), change the filter located on the tubing of the water tank.
a. Remove the old filter.
b. Replace by a new filter (Fluid, Inline Filter F10B40253) by following the arrow corresponding
to the water flow on the side of the filter.
1 = To the water tank
2 = To the instrument
12. Repeat steps 9 and 10 once.
See also:
■ Sequence, p.244
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1.3. Monthly Procedures
1.3.1. To Change ISE Solutions
Follow this procedure to change ISE solutions (Standard 1 and Reference) from the ISE
solution compartment.

■ Tools and consumables used during this procedure: Standard 1 (ABX Pentra Standard 1
A11A01717) and Reference solutions (ABX Pentra Reference A11A01719).

2. Open the ISE solution compartment cover.
3. Unscrew each cap with tubing and straw from the bottle and dry the straw.
4. Remove the bottles from the ISE solution compartment.
5. Install the new bottles in the ISE solution compartment.
6. Screw each cap with tubing and straw on the new corresponding bottle.
8. Reset the bottle volume:
a. Open the WorkHour screen: Services > Customer Services > WorkHour (tab) .
b. Press Reset for L solution (Standard 1) or Ref solution (Reference).
Only level 2 users (L2) are allowed to reset the bottle volume.
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9. Refill the tubing with new solutions:

a. Open the Sequence screen: Services > Customer Services > Sequence (tab) .
b. Type 10 on the right of the ISE Prime button to run 10 primes.
c. Press ISE Prime.
Wait until the end of the primes: instrument status changes from "ANALYSING" to "READY".

11. Check that there is no leakage at the connections.
12. Close the ISE solution compartment cover.
See also:
■ Sequence, p.244
1.3.2. To Perform the Precision Test 1 (T1)
Follow this procedure every month to check pipetting accuracy and precision.
Access: Inventory > Reagent Tray

■ Tools and consumables used during this procedure: Qualitest solution (ABX Pentra Qualitest
Solution A11A01758).

3. Fill the 30 mL compartment of the open cassette (30/10) n°701 with 25 mL of distilled water.
4. Load the cassette on the reagent tray.
5. In a sample cup prepare 500 µL of Qualitest solution (ABX Pentra Qualitest Solution
A11A01758) diluted by two.
6. Load the T1 test sample cup with adapter on the sample tray at an available position.
Caps must be removed from the sample cups as they may hit the Sample and Reagent

9. Press Barcode Scan from the Reagent Tray screen ( Inventory > Reagent Tray ).
10. In Main menu > Order > Selection (tab) , register the T1 test solution:
a. Select the T1 test sample cup position.
b. Select Replicate in the Type dropdown list.
c. Select Biocup from the Cup dropdown list.
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d. Select 15 from the Number dropdown list.

e. Choose the T1 test by checking the corresponding box.
f. Press Save to save T1 test registration.
11. Press Start button for more than two seconds.
12. Open the Patient tab from the Run screen.

13. When all the ordered test analysis are performed (15), use the results to calculate the mean and
the coefficient of variation (CV).
The expected CV is ≤1.8%. If the expected coefficient of variation is not obtained, please refer to
the Troubleshooting chapter (see Maintenance and Troubleshooting > Troubleshooting chapter).
Mean = (result1 + result2 + ... + resultn)/n
SD = √[[(result1 - mean)2 + (result2 - mean)2 + ... + (resultn - mean)2]/n-1]
CV = (SD/mean) * 100
Where:
■ n is the number of replicates (15)
■ SD is the standard deviation
1.3.3. To Replace Syringe Plunger Tip
Follow this procedure to replace syringe plunger tip.

■ Tools and consumables used during this procedure: paper towel, syringe tip insertion tool, 3 mm
hexagonal key, Phillips® screwdriver, pliers, syringe tip, silicon oil (Oil silicon tips XEC086AS).
To ensure good pipetting precision, replace the syringe plunger tips after the recommended work
hours for each of them. Work hours for each syringe are monitored and displayed in the WorkHour tab.
■ SPP - Sample syringe: 600 hours (approximately six months)
■ RPP - Reagent syringe: 300 hours (approximately three months)
■ WPP - Wash syringe: 300 hours (approximately three months)
If a syringe tip needs to be replaced, a warning is displayed in a pop-up to inform user that the
recommended work hours of the syringe have been reached.
1. Remove the syringe cover (1) to access to the syringes as follows:

a. Unscrew the two screws (2) of the cover with the Phillips® screwdriver provided in the
installation kit.
b. Pull the two plastic clips (3) to remove the cover.
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1 = Syringe cover
2 = Screws
3 = Plastic clips
2. Place a paper towel under the syringe to absorbe water leakage.

3. Unscrew the hexagonal screw of the plunger block using the hexagonal key provided in the
installation kit.
1 = Wash pump unit (WPP)
2 = Reagent pump unit (RPP)
3 = Sample pump unit (SPP)
4 = Hexagonal screw
4. If dismantling the sample syringe (3), unscrew the plastic holder at the bottom of the syringe.
5. Pull down the plunger to remove it.
1 = Plastic holder
2 = Washer
3 = Three joints
4 = Plunger
5 = Plunger tip
Wash pump unit and reagent pump unit do not have holder, washer nor joint.
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6. Remove the plunger tip by pulling it with pliers:
When removing the tip never bend the plunger.
7. Insert the new tip in the corresponding hole of the syringe tip insertion tool, hold the plunger
vertically and insert it.
■ Sample syringe tip (SPP syringe tip (x10) F10B26109)
■ Reagent syringe tip (RPP syringe tip (x10) F10B05508)
■ Wash syringe tip + O'ring (WPP syringe tip (x10) F10B05511)
8. Apply uniformly silicon oil to 3/4 height of the tip attached to the plunger as shown below.
1 = Silicon oil application range
2 = Plunger
9. Carefully insert the plunger back into the syringe and push it upward.
10. Move the plunger to the right position and screw the plunger block.
11. Remove the paper towel.
12. Screw the cover back on.
13. Switch on the instrument.
14. Reset the work hours of the corresponding syringe in Services > Customer Services >
WorkHour (tab) .
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15. Type 10 next to the Prime button to prime the system 10 times in Services > Customer Services
> Sequence (tab) .
16. Press Prime.
Check pipetting accuracy and precision by performing the precision test 1 procedure. See
Maintenance and Troubleshooting > Maintenance > Other Procedures > To Perform the Precision Test
1 (T1) chapter.
See also:
■ To Perform the Precision Test 1 (T1), p.214
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1.4. Yearly Procedures
1.4.1. To Replace the Probe
Follow this procedure to replace the probe if damaged or once a year in order to ensure
accurate measurements.

■ Tools and consumables used during this procedure: paper towel, probe (Probe F10B40255),
hexagonal key.
1. Remove the probe arm cover by pulling slightly the clips under the probe arm base.
2. Disconnect the probe connector:
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3. Place a paper towel under the connection to absorbe water leakage.

4. Lift up the probe unit by hand and place it above the wash tower as water will leak.
5. Hold the probe side connector and unscrew the probe screw nut (tube side).
■ Never use tools to unscrew.

■ Never twist the probe side connector.
6. Loosen the hexagonal screw (bottom screw) using the hexagonal key provided in the installation kit.
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7. Remove the probe.

8. Install the new probe (Probe F10B40255). Reassemble in reverse order.
■ Make sure that the probe is not bent.

■ Make sure that nothing is trapped between the probe horizontal part and the probe
arm and that the probe is in good position.
9. Check that the length between the lowest end of the probe and the arm base is 130.5 mm.
10. Hold the probe vertical part between two fingers and gently move up and down to check that it
can move smoothly.
11. Put the cover arm back and return the probe arm by holding it up to the wash tower position.
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1.5. Other Procedures
1.5.1. To Replace ISE Electrodes
1.5.1.1. To Perform ISE Electrode Exchange
Follow this procedure to replace ISE electrodes.

■ Tools and consumables used during this procedure: Phillips® screwdriver, ISE electrode, Etching
cassette (ABX Pentra Etching CP A11A01769).
1. Press ISE Electrode Exch to remove solutions from the tubes.

A pop-up is displayed: "ISE module is ready for electrode exchange. Run activation process after
the exchange for adaptation."
2. Press OK.
A pop-up is displayed.
3. Press Shutdown.
4. Switch off the analyzer when the pop-up disappears by pressing the power switch, on the right-
hand side of the instrument.
7. Remove the used electrode. If reference electrode needs to be changed, disconnect the two
tubes.
8. Unpack the new electrode.
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Please note that the electrodes can be installed up to the date mentioned on the
packaging label.
9. Remove the protection from each side of the electrode.

10. If replacing the Na+ ISE electrode, a manual etching needs to be performed:
a. Open the Etching cassette (ABX Pentra Etching CP A11A01769).
Gloves must be worn when using Etching solution.
b. Take 10 µL of Etching solution with a pipette.

c. Fill the sample channel of the Na+ ISE electrode with the Etching solution by the hole at the
opposite of the O-ring side.
d. Leave the Etching solution in the sample channel of the Na+ ISE electrode for two minutes.
e. Remove the Etching solution from the sample channel by capillarity with a paper towel.
11. Check that the O-ring is well-positioned on one side of the electrode.
12. Install the new electrode.
When facing the ISE module, the electrodes have to be positioned to their appropriate position:
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For reference electrode, connect the two tubes to their appropriate position. For the
upper position connect the tubing labeled "R7" and for the lower position connect the
tubing labelled "E1".
13. Close the ISE module cover and tighten the screw.
15. Perform an ISE Prime in Services > Customer Services > Sequence (tab) :
a. Type 5 on the right of the ISE Prime button to run five primes.
b. Press ISE Prime.
Wait until the end of the primes: instrument status changes from "ANALYSING" to "READY".

17. Screw the ISE cover back.
18. Reset the work hours of the electrode changed in Services > Customer Services > WorkHour
(tab) .
Only level 2 users (L2) are allowed to reset the electrodes work hours.
See also:
■ Sequence, p.244
exchange.

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See also:
1.5.2. To Replace Dust Bag
Follow this procedure to change the dust bag.

■ Tools and consumables used during this procedure: dust bag (Waste Bags (x100) A11A01915),
waste bag inserting tool (Waste Bag Insertion Tool F10B40318), rubber band.

2. Remove the dust pod from the instrument.
3. Remove the lid and the plastic bag.
4. Discard the plastic bag containing used cuvettes.
Dispose of used cuvettes according to your local/national guidelines for biohazard

waste disposal.
5. Prepare the waste bag inserting tool:
1 = Dot line
2 = Insertion tag
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a. Bend the plastic sheet according to the dotted lines to get a square shape.
b. Insert the insertion tags into the incision to maintain the shape.
6. Take a new dust bag and insert the waste bag inserting tool into the dust bag.
7. Insert the dust bag with the tool into the dust pod and push it to the bottom.
8. Place the edge of the dust bag outside the dust pod and hold them with a rubber band on the dust
pod.
9. Remove the waste bag inserting tool.

10. Place the lid on the dust pod.
11. Place the dust pod back into the instrument.
Check that the dust pod lid is completely engaged (a click sound is heard). If not it
could collide with the loading unit during measurement.

13. Open the Remaining Cuvettes screen ( Main menu > Remaining Cuvettes ).
The cuvette waste counter should be automatically reset to 216.
14. If the cuvette waste counter is not reset to 216, press Reset in the Cuvette waste area.
1.5.3. To Clean the Covers
Follow this procedure to clean the covers of the instrument.

■ Tools and consumables used during this procedure: gauze or paper towel, disinfectant product.
The external surfaces of the instrument must be decontaminated considering the biological environment.
Wipe the surface of the instrument with gauze or paper towel moistened with disinfectant product.
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Never use ethanol to clean the instrument covers.

ANIOS detergent disinfectant, (WIP’ANIOS 1316.424) can be used.
See also:
■ To Clean the Probe with Deproteinizer, p.128
1.5.4. To Unblock the Probe
Follow this procedure to clean the probe if clogged.

■ Tools and consumables used during this procedure: gauze, 70% ethanol, cleaning jig (Probe
Cleaning Jig F10B05964), disinfectant product, deproteinization solution (ABX Pentra
During sampling, the probe may clog. An unblocking procedure must be followed to ensure accurate
and reliable results.
Ethanol is used during this procedure. Do not handle ethanol close to fire or high
temperature parts/units.
1. Remove the Sample and Reagent Container Unit (SRCU) cover. Remove the sample and reagent
trays.
2. Lift up the probe unit by hand and place it above the SRCU.
3. Gently wipe the probe from top to bottom with a gauze moistened with 70% ethanol.
■ Gentle handling is recommended. Avoid bending the probe arm or the probe while
cleaning.
■ Never wipe the probe from bottom to top as it may damage the probe and/or insert
gauze fragments into the probe.
4. Use the cleaning jig to clean the inside part of the probe. Insert the thin cleaning wire in the probe
and remove it.
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1 = Probe
2 = Cleaning Jig
3 = Thin cleaning pointer
4 = Thick cleaning pointer
5 = Direction to insert
5. Gently wipe the probe from top to bottom with a gauze moistened with distilled water.
6. Dry the probe with soft cloth.
7. Return the probe arm to the wash tower position.
9. Place a deproteinizer cassette in the reagent tray.
10. Enter in Services > Customer Services > Sequence (tab) to clean the probe with deproteinizer
solution.
11. Select the special washing solution in the Special Probe Wash area.
12. Press Exec button.
13. Check pipetting accuracy and precision by performing the precision test 1 procedure. See
Maintenance and Troubleshooting > Maintenance > Other Procedures > To Perform the Precision
Test 1 (T1) chapter.
See also:
■ Sequence, p.244
1.5.5. To Decontaminate the Instrument
Follow this procedure to decontaminate externally and internally your instrument.

■ Tools and consumables used during this procedure: soft cloth, gauze or paper towel, disinfectant
product.
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■ Never spill liquid on the instrument.

■ Never use disinfectant product* that contains alcohol.
1. Decontaminate the screen:

a. Use a soft cloth slightly wet with disinfectant product*.
b. Gently wipe the screen.
c. Dry to remove any trace of moisture.
2. Decontaminate the probe and the mixer by following the probe cleaning procedure. See
Maintenance and Troubleshooting > Maintenance > Weekly Procedures > To Clean the Probe with
Deproteinizer chapter.
3. Decontaminate the Sample and Reagent Container Unit (SRCU):
a. Perform the SRCU cleaning procedure and do not put back the sample and reagent trays in
place. See Maintenance and Troubleshooting > Maintenance > Daily Procedures > To Clean
Sample and Reagent Container Unit chapter.
b. Wipe the surface of the instrument with gauze or paper towel moistened with disinfectant
product.
4. Decontaminate the covers by following the cover cleaning procedure. See Maintenance and
Troubleshooting > Maintenance > Optional Procedures > To Clean the Covers chapter.
See also the W.H.O (World Health Organization) guidelines: «Laboratory Biosafety
Manual, 3rd edition», for further information.
* Disinfectant product must have the following microbiological properties:

■ Bactericidal
■ Fungicidal
■ Active on Aspergillus fumigatus
■ Active on Mycobacterium tuberculosis (BK)
■ Antiviral (VIH, HBV and rotavirus)
Product example validated by HORIBA Medical:

ANIOS detergent disinfectant (WIP’ANIOS 1316.424).
See also:
■ To Clean the Covers, p.226
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1.5.6. To Replace the Lamp
Follow this procedure to replace the halogen lamp.
■ Switch off the instrument and wait 30 minutes before starting this procedure.
■ Tools and consumables used during this procedure: lamp (Halogen Lamp F10B40310), Phillips®
screwdriver.
To ensure accurate measurements, replace the halogen lamp after the recommended work hours.
Work hours for the lamp are monitored and displayed in the WorkHour tab.
1. Unscrew the lamp cover with the Phillips® screwdriver provided in the installation kit.
During this replacement procedure take care not to hit the probe.
2. Remove the cover.
Risk of personal injury due to hot surfaces within the instrument. Wait for the lamp to
cool down before proceeding.
3. Release the lamp cable from the holder.
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1 = Connector
2 = Holder
4. Unplug the lamp connector by pressing the clip and pulling.
1 = Press
2 = Pull
5. Unscrew the screw holding the lamp case (unnecessary to remove the screw).
6. Take out the lamp case by holding the white handle.

7. Loosen the two screws and remove the halogen lamp.
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8. Replace by the new lamp (Halogen Lamp F10B40310) and reassemble in reverse order.
Do not touch the halogen lamp with fingers. If necessary use a soft cloth.
Good position: Bad position:

10. Enter in Services > Customer Services > WorkHour (tab) .
11. Reset the work hours of the lamp.
See also:
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1.5.7. To Perform an Extended Shutdown with ISE
Follow this procedure to shutdown an instrument with an ISE module for a prolonged
period of time.
1. Perform the weekly maintenance procedure until the probe cleaning with deproteinizer.
2. Perform the procedure for tubing and external tanks decontamination.
3. Perform an extra prime without water to drain the system.
6. Unscrew each cap with tubing and straw from the bottle and dry the straw.
7. Remove the bottles from the ISE solution compartment and close them with their caps.
Once open, the ISE solutions are stable for one month if stored at 5-30°C and
protected from light.
8. Type 10 next to the ISE Prime button.

9. Press ISE Prime.
Wait until the end of the prime: status "READY".
10. Plunge the straws into a distilled water bottle.

12. Press ISE Prime.
13. Remove the straws from the distilled water bottle and dry them.
15. Press ISE Prime.
16. Press ISE Electrode Exch. to discharge the liquid from the tube.
The pop-up message "Please turn off the power" is displayed.
17. Switch off the analyzer when the pop-up disappears by pressing the power switch, on the right-
hand side of the instrument.
20. Remove the electrodes and the air sensor from the ISE cage.
a. For the sodium, chloride and potassium electrodes as for the air sensor, ensure there is no
liquid into the inner tube.
b. For the reference electrode, put a tubing filled with reference solution between the two
connectors and seal the inner tube with a cellophane tape.
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c. Store the electrodes in a dry and clean area in their original package.
21. Close the ISE cover on the left-hand side of the instrument (two screws).
22. Remove the cuvettes racks and protect them with their covers.
23. Empty the dust pod.
Dispose of waste according to your local/national guidelines for biohazard waste

disposal.
24. Remove the samples from the sample tray.

25. Close the cassettes with their caps and place the complete tray at 4-8°C.
26. Empty, then clean and dry the DET.W bottles.
See also:
■ To Switch On Instrument with ISE after an Extended Shutdown, p.235
■ To Perform Tubing and External Tanks Decontamination, p.211
1.5.8. To Perform an Extended Shutdown without ISE
Follow this procedure to shutdown an instrument without ISE module for a prolonged
period of time.
1. Perform the weekly maintenance procedure until the probe cleaning with deproteinizer.
2. Perform the procedure for tubing and external tanks decontamination.
3. Perform an extra prime without water to drain the system.
4. From the main screen press the Shutdown button in the generic toolbar at the top of the screen.
5. Press Power Off.

The pop-up disappears and the window becomes black when the shutdown cycle is finished.
6. Wait until then to switch off the instrument by pressing the power switch, on the right-hand side of
the instrument.
7. Remove the cuvettes racks and protect them with their covers.
8. Empty the dust pod.
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disposal.
9. Remove the samples from the sample tray.

10. Close the cassettes with their caps and place the complete tray at 4-8°C.
11. Empty, then clean and dry the DET.W bottles.
See also:
■ To Switch On Instrument without ISE after an Extended Shutdown, p.237
1.5.9. To Switch On Instrument with ISE after an Extended Shutdown
Follow this procedure to switch on an instrument with an ISE module after an extended
shutdown.
3. Install the electrodes.
When facing the ISE module, the electrodes have to be positioned to their appropriate position:
For reference electrode, connect the two tubes to their appropriate position. For the
upper position connect the tubing labelled "R7" and for the lower position connect the
tubing labelled "E1".
4. Close the ISE module cover and tighten the screw.

5. Close the ISE cover on the left-hand side of the instrument (two screws).
8. Install the ISE solution bottles (Standard 1 and Reference) in the ISE solution compartment.
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9. Screw each cap with tubing and straw on the corresponding bottle.
11. Fill the water tank.
13. If new bottles are used, reset the bottle volume in Services > Customer Services > WorkHour
(tab) . Press Reset for L solution (Standard 1) or Ref solution (Reference).
Only level 2 users (L2) are allowed to reset the bottle volume.
14. Fill the tubing with the solutions:

a. Open the Sequence screen Services > Customer Services > Sequence (tab) .
b. Type 10 on the right of the ISE Prime button.
c. Press ISE Prime to run 10 primes.

17. Close the ISE solution compartment cover.
18. Type 10 on the right of the Prime button.
19. Press Prime to fill the system with distilled water.
See also:
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1.5.10. To Switch On Instrument without ISE after an Extended Shutdown
Follow this procedure to switch on an instrument without ISE module after an extended
shutdown.
1. Fill the water tank.

3. Open the Sequence screen Services > Customer Services > Sequence (tab) .
4. Type 10 on the right of the Prime button.
5. Press Prime to fill the system with distilled water.
See also:
■ To Perform an Extended Shutdown without ISE, p.234
1.5.11. To Stop in Emergency During Analysis
Follow this procedure to stop the instrument during analysis if you identify a mistake in
your order or need to stop the instrument for any reason (water empty, waste full, cuvettes
shortage, ...).
1. Press two seconds on the emergency stop button.
1 = Green LED
2 = Red LED
3 = Emergency stop button
■ The analysis in process is stopped.

■ The status turns to "STOPPED".
■ The alarm icon turns to red and the alarm message "Detected stop request" is displayed.
■ A pop-up with several choices (Power Off, Restart, Cancel) is displayed.
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2. Press Cancel.
The door is unlocked and can be opened by the user.
3. If you need to change or to add sample or reagent.

a. Open the main cover.
b. Open the Sample and Reagent Container Unit (SRCU) cover.
c. If adding reagent or changing reagent position, perform a barcode scan from the Inventory
screen.
A barcode scan must be performed as soon as a cassette is installed on board,

replaced, moved or removed.
d. If adding sample or changing sample position, delete and register a new worklist ( Main menu
> Order > Selection (tab)).

6. Press Start.
A prime is automatically performed at the beginning.
1.5.12. Backup and Database Management
The Backup screen allows to save or to load system parameters, to save or to load the database, to
manage the database and to configure the auto backup.
1 = Parameters
backup
2 = Database
backup
3 = Database
management
4 = USB auto
backup
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It is recommended to save periodically the system parameters and results for safety.
See also:
■ To Save or To Load System Parameters, p.239
■ To Save or To Load the Database, p.240
■ To Manage the Database, p.241
■ To Configure the Auto Backup, p.141
1.5.12.1. To Save or To Load System Parameters
Follow this procedure to save or to load the database configuration (without results).
A USB key must be used to save data from the instrument or to load data into the instrument.
■ Never use port n°4 to connect the USB key.

■ Never switch off the instrument with the main switch before the end of the backup.
Only level 2 users (L2) are allowed to manage parameter backup.
The parameters backup allows to save the database without results. The following data are not saved:
■ Patient results, calibration results, control results
■ QC
■ Cassette inventory
■ Users
■ Maintenance settings
■ Open cassettes configuration
■ Patient registered
1. To save or to load parameters, select your USB directory by pressing the path access button.
2. Press Save Parameters: Exec to save the parameters from the instrument to your USB key or
Load Parameters: Exec to load the parameters from the USB key to the instrument.
The database file name format is: DBBack_YYYYMMDDhhmmss.

■ YYYY: year
■ MM: month
■ DD: day
■ hh: hour
■ mm: minute
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■ ss: second
Instrument must be shutdown after parameter loading.
After parameter loading, perform the following checks:

■ Check calibration settings and the reagent lot number associated,
■ Check control lot number and target values,
■ Check agreement between cuvettes registered and cuvettes in the racks,
■ Empty the dust pod.
1.5.12.2. To Save or To Load the Database
Follow this procedure to save or to load the database.

Level 1 users (L1) are allowed to save the database but only level 2 users (L2) are allowed
to load a database.
The database backup allows to save or to load the complete database (results and system parameters).
1. To save or to load parameters, select your USB directory by pressing the path access button.
2. Press Save Database: Exec to save the database from the instrument to your USB key or Load
Database: Exec to load the database from the USB key to the instrument.
The database file name format is: DBBackupsave_YYYYMMDDhhmmss.

■ YYYY: year
■ MM: month
■ DD: day
■ hh: hour
■ mm: minute
■ ss: second
Instrument must be shutdown after database loading.
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After database loading, perform the following checks:

■ Perform a barcode scan,
1.5.12.3. To Manage the Database
Follow this procedure to delete all results or to restore the database.

Only level 2 users (L2) are allowed to manage the database.
1. If all results need to be deleted, press Delete all results: Exec.

All patient results, control results and alarms are deleted from the database.
Calibrations are not deleted.
2. If the database needs to be restored, press Restore DB: Exec.

At the end of each run, the results are saved to the database. The last saving date of the database
is displayed.
The last database is restored from the internal memory.
Initialize DB
■ Only engineers (EL) are allowed to initialize the database. All registered users will be
lost by this action.
■ The complete database is deleted from the instrument. All results and settings are
deleted.
■ The instrument must be shutdown after database initialization.
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The instrument must be shutdown after database loading.
After database loading, perform the following checks:

■ Perform a barcode scan,
1.5.13. To Save the Log File
Follow this procedure to save the log file from the instrument to your USB key.
Access: Main menu > Services > System Configuration > Setup2 (tab)
■ A USB key must be used to save data from the instrument or to load data into the instrument.

■ The Send log file check box must be selected. Data about the instrument are archived only when
it is selected.
The log file is used by engineers to check the instrument. The log file can be saved in case of
problems by level 2 users (L2) or engineers (EL).
1. Select the directory using the path access button.

2. Press Send to send the current log file to the USB key.
1.5.14. List of Consumables and Spare Parts
The table below provides to the user a complete list of consumables and spare parts that may be
needed on the instrument.
Maintenance list
Designation Reference
ABX Pentra Deproteinizer CP A11A01754
ABX Pentra Clean-Chem CP A11A01755
ABX Pentra Qualitest Solution A11A01758
Fluid, Inline Filter F10B40253
WPP Syringe Tip (x10) F10B05511
RPP Syringe Tip (x10) F10B05508
SPP Syringe Tip (x10) F10B26109
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Oil Silicon Tips XEC086AS
Probe F10B40255
Halogen Lamp F10B40310
WIP’ANIOS 1316.424
Consumables list
Sample Cup - Blue (x1000) A11A01765
Sample Cup - Green (x1000) A11A01766
Sample Cup - White (x1000) A11A01767
Sample Cup - Yellow (x1000) A11A01768
Waste Bags (x100) A11A01915
Cuvette Racks (60 racks) A11A01914
Kit Cassette 30-10mL (6 cassettes + caps) A11A01922
Stickers for Reagent Cassettes on Pentra C200 HAX0297B
Spare parts list
User Manual CD-ROM RAX072A
Daily Guide RAB275AEN
Waste Tank (without ISE) F10B40211
Waste Tank (with ISE) F10B40212
Water Tank F10B40213
Plastic Pen for Touch Screen HAN516C
Fluid, DET Bottle (x10) F10B40092
Sample Tray F10B40189
Reagent Tray F10B40190
Syringe Tip Insertion Tool F10B05780
Waste Bag Insertion Tool F10B40318
Sample cup Adapter F10B40314
Probe Cleaning Jig F10B05964
ISE consumables and spare parts list
ABX Pentra Etching CP A11A01769
ABX Pentra Deproteinizer CP A11A01754
ABX Pentra Dummy Electrode A11A01851
Cleaning kit for ABX Pentra Chloride-E XEA935AS
ABX Pentra Standard 1 A11A01717
ABX Pentra Reference A11A01719
ABX Pentra Chloride-E A11A01739
ABX Pentra Potassium-E A11A01740
ABX Pentra Sodium-E A11A01738
ABX Pentra Reference-E A11A01741
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1.6. Customer Services
The Customer Services menu allows you to perform the maintenance of the instrument and to check
the performance.
Access: Main menu > Services > Customer Services
Customer Services menu is divided in five screens:

■ Sequence
■ Performance
■ WorkHour
■ Sleep
■ Version
1.6.1. Sequence
The Sequence screen allows to perform maintenance operations.

1 = Chemistry
units operations
2 = ISE unit
operations (option)
3 = Initialization
process
management
4 = Maintenance
wash of the probe
5 = DET.W auto
dilution
6 = Calibration of
touch panel
Sequence operations
Sequence operations buttons allow to perform specific operations used during maintenance of the
instrument.
Legend Description
Initialization To initialize the instrument.
Prime To fill the tubing of the instrument with distilled water from the water tank.
Number of primes must be specified in the field next to the Prime button.
DET.W Volume Check To check the volume of solution in the probe's DET.W bottle. The volume
measured is displayed in the field next to the DET.W Volume Check button.
Cuvette Disposal To remove all the cuvettes from the incubation and reaction unit.
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Legend Description
MIX Ascend or MIX Descend To ascend (or descend) the mixer unit.
This option is not available for level 1 users (L1).
CLU Positioning To adjust the positions of the cuvette loading unit.
Only available for engineers (EL).
Tubing Wash To wash tubing for system decontamination.
ISE Prime To fill the ISE tubing. Number of primes must be specified in the field next to the
ISE Prime button.
ISE Calibration To calibrate the ISE. The calibrator must be specified from the Order screen.
Refer to the ISE Calibration chapter (see Workflow > Calibration and Control > ISE
Calibration > To Calibrate ISE chapter).
ISE Cleaning To clean ISE electrodes with deproteinization solution (ABX Pentra Deproteinizer
CP A11A01754). Refer to the ISE Cleaning with Deproteinizer chapter (see
Maintenance and Troubleshooting > Maintenance > Weekly Procedures > To
Clean ISE with Deproteinizer chapter).
ISE Cleaning 2 To clean ISE electrodes with etching solution (ABX Pentra Etching CP
A11A01769). Refer to the ISE Cleaning chapter (see Maintenance and
Troubleshooting > Maintenance > Weekly Procedures > To Clean ISE chapter).
ISE Electrode Exch. To remove the solutions from the ISE tubing for ISE electrodes replacement. Refer
to the ISE Electrodes Replacement chapter (see Maintenance and
Troubleshooting > Maintenance > Other Procedures > To Replace ISE Electrodes
chapter).
ISE Activation To perform ISE electrodes activation after electrode replacement. The activator
must be specified from the Order screen.
ISE Drain To remove all solutions from ISE tubing for tubing replacement.
Initialization management
The Run prep skip check box allows to skip the initialization of the instrument (priming and lamp
autogain) at run start.
To be used only by engineers for technical purpose.
Maintenance probe wash

The Special Probe Wash area allows to specify and to perform a probe wash.
The Presoak Probe Wash area allows to specify and to perform a 10-minute presoak of the probe.
Legend Description
Water The distilled water from the water tank is used to wash the probe.
Special The solution from a specified cassette from the sample and reagent container unit
is used to wash the probe. The special wash solution has to be defined in the
Setup screen ( Main menu > Services > System Configuration > Setup ).
DET.W The solution from the DET.W bottle is used to wash the probe.
DET.W auto dilution

The DET.W auto dilution allows to prepare new DET.W solution from a concentrated solution located
in the sample and reagent container unit. To use this option, place the concentrated solution in a
sample cup in position 1 on the sample tray. Choose the dilution ratio, remove any remaining solution
from the probe's DET.W bottle and press Exec. The instrument automatically performs the dilution in
the probe's DET.W bottle. To perform the dilution for the mixer's DET.W bottle, exchange the DET.W
bottle position.
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Caps must be removed from the sample cups as they may hit the Sample and Reagent
Calibration of touch panel

If user has problems selecting items on the screen, the LCD screen needs to be calibrated to redefine
the precision of the pressing point. To calibrate the touch panel press Exec. A white screen is
displayed with an arrow pointing at a red dot. Use a soft and thin tool to press on the red dot. Nine
red dots are displayed one after the other, press each of them. The new calibration is automatically
saved after pressing on all the red dots.
See also:
■ To Clean ISE with Etching (Option), p.126
■ To Clean ISE with Deproteinizer, p.202
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1.6.2. Performance
The Performance screen allows to check the detector performance and the temperature in the
Incubation Reaction Unit (IRU) and in the Sample and Reagent Container Unit (SRCU).
Access: Main menu > Services > Customer Services > Performance (tab)
1 = Temperature
variation in the IRU
during the last 10
minutes
2 = Current
temperature in the
IRU
3 = Current
temperature in the
SRCU
The Performance screen is divided in two areas:

■ The Temperature Control area
■ The Detector Performance Monitor area
Temperature control
Temperature of the IRU is measured in real time for two points in the IRU and is displayed in numeric
value (2).
The temperature is displayed as a graph only for engineers (EL).
Temperature of the SRCU is also displayed in real time. Only the numeric value is available.
The temperature offset (calibrating value) is displayed for each temperature.
Target values:
■ The IRU temperature should be 37°C ± 0.3°C (99°F ± 33°F),
■ The SRCU temperature should be 8°C - 15°C (46°F - 59°F).
Detector performance monitor

The spectrophotometer auto gain is measured at the start of each run. The gain is defined by two
values for each wavelength available on the instrument.
■ The Mag is the rough value of the gain (from 1 to 3),
■ The Gain is the fine value of the gain (from 1 to 255).
The combination of both values allows the engineer to check the performance of the
spectrophotometer and the lamp. Performance are bad for a specific wavelength when the Mag value
is 3 and the gain value 1.
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See also:
■ Temperature Problems, p.257
1.6.3. Work Hours
The WorkHour screen allows to check the use of each unit and the need for maintenance or change.
1 = General
operations counter
2 = Results
capacity
3 = Syringes
counter
4 = Detector
counter
5 = Pumps counter
6 = Technical
maintenance
counter
7 = ISE counter
(option)
The counters display:

■ The unit part,
■ The remaining use before replacement,
■ The maximum use before replacement (in brackets),
■ A reset button to reset the counter when the part is replaced.
The remaining time before replacement is displayed in yellow when the value goes under
10 hours and in red when the value goes under 0 (zero) hours. Under 0 (zero), the value is
displayed with a minus.
Legend Description
Total working hours Displays the total operation time.
Total test Displays the total number of tests.
Result Memory: All Displays the maximum memory capacity for all results except QC results (in
number of tests).
Result Memory: QC Displays the maximum memory capacity for QC results (in number of tests).
Result Memory: STD Displays the maximum memory capacity for calibration results (in number of tests).
Result Memory: ISE STD Displays the maximum memory capacity for ISE calibration results (in number of
tests).
Microsyringe Tip: RPP Displays the use of the RPP (reagent pump unit) syringe tip (in hours).
Microsyringe Tip: SPP Displays the use of the SPP (sample pump unit) syringe tip (in hours).
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Legend Description
Microsyringe Tip: WPP Displays the use of the WPP (wash pump unit) syringe tip (in hours).
Halogen Lamp Displays the use of the halogen lamp (in hours).
Diaphragm Pump: Probe Displays the use of the pump supplying water to the probe's trough for probe
wash (in hours).
Diaphragm Pump: MIX-T Displays the use of the pump supplying water to the mixer's trough for mixer
wash (in hours).
Check: 6 Month Displays the need for the 6-month technical maintenance (in days).
Check: 1 Year Displays the need for the yearly technical maintenance (in days).
ISE: Na Electrode Displays the use of Na+ electrode (in days).
ISE: Cl Electrode Displays the use of Cl- electrode (in days).
ISE: Pump Tube Displays the use of the ISE tubing (in days).
ISE: L Solution Displays the volume of Standard 1 solution (in mL).
ISE: K Electrode Displays the use of K+ electrode (in days).
ISE: Ref Electrode Displays the use of Ref electrode (in days).
ISE: Ref Solution Displays the volume of Reference solution (in mL).
1.6.4. To Set Sleeping Mode


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1.6.5. Version
The Version screen allows to check the program version of the instrument.
Access: Main menu > Services > Customer Services > Version (tab)
Legend Description
UI Main Version number of the user software.
Unit Main Version number of the mechanical software.
Unit DTR Version number of the spectrophotometer software.
Unit ISE Version number of the ISE software.
OS Version number of the embedded operating system "XPe".
DB Version number of the database.
OS Patch Version number of patch update.
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Pentra C200 maintenance schedule
MONTH:
Maintenance
251
DAILY
Day: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
ISE cleaning with Etching (end of day if > 20 tests)
SRCU drying (end of day)
Probe cleaning with deproteinizer (shutdown or sleep)
WEEKLY
Frequency Week:
1 week Check ISE solutions
1 week ISE cleaning with deproteinizer
1 week ISE cleaning with Etching (if < 20 tests)
1 week External probe cleaning
1 week DET.W solution replacement
2 weeks Tubing and tanks cleaning
MONTHLY ISE
Frequency Date ISE reagents replacement Date Lot #
1 month Precision test (T1) Standard 1
Maintenance Schedule
3 months Wash syringe plunger tip replacement Standard 2

3 months Reagent syringe plunger tip replacement Reference
6 months Sample syringe plunger tip replacement Electrodes replacement Date Lot #
6 months Filter replacement Reference
Sodium
ON REQUEST Chloride
Potassium
Date
Probe replacement
Probe unblocking
Lamp replacement
Ref: RAB274BEN
Instrument cleaning and decontamination
User Manual
1.7.
Troubleshooting
2. Troubleshooting
This chapter provides instructions for solving problems that may occur when using the Pentra C200
analyzer.
If a mechanical or electrical problem is suspected, do not perform inspection of the

analyzer by yourself and contact your HORIBA Medical representative.
2.1. Operation Problems
2.1.1. Power Problems
Follow this procedure if you have problems starting your analyzer.
1. Check that the main switch, on the right-hand side of the anlayzer is on (I).
2. Check that the power cord is properly connected.
3. Check that the instrument is getting power from the wall outlet.
4. Check the main fuse:
a. Make sure that the main switch, on the right-hand side of the instrument is off (0).
b. Unplug the power cable from the analyzer.
c. Pull out the fuse holder.
d. Check the two fuses.
e. If necessary change the fuses by new ones in the installation kit.
f. Put back the fuse holder.
g. Plug the power cable.
If the problem persists, please contact your local HORIBA Medical representative.
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2.1.2. Printer Operation Problems
Follow this procedure if the printer does not work.
To install the printer you need the help of your HORIBA Medical representative.
1. Check that the printer power cord is connected properly.

2. Switch off and on the printer.
3. Check the paper feed.
4. Refer to your printer's user manual.
2.2. Analysis Cycle Problems
2.2.1. Undetected Cassette
Follow this procedure if the instrument fails to detect a cassette on the reagent tray.
Cassettes are automatically detected when placed on the reagent tray and a Barcode Scan is
performed from the Reagent Tray screen or when starting measurements. If a cassette placed on the
reagent tray is not displayed after a barcode scan, follow the following steps.
Open cassettes need to be registered before barcode scan in the Inventory > Open
Cassette (tab) screen.
1. Press Barcode Scan and wait until the end of the scan.
2. If the cassette is not displayed on the reagent tray representation, open the main cover and the
sample and reagent container unit cover.
3. Check physically the cassette position and the expected position on the tray representation in the
Reagent Tray screen.
4. Remove the reagent tray.
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5. Check the barcode on the cassette.

6. If the barcode sticker is dirty or show sign of condensation, clean it and dry it with a soft paper towel.
7. Check the barcode location according to the sticker location specifications given in the Reagent
chapter (see Description and Technology > Instrument Description > Fluid Storage Module >
Reagent chapter).
8. If necessary, for open cassette, remove the sticker and stick a new one to the appropriate location.
9. Check that the reagent is registered in Main menu > Services > System Configuration >
Reagent (tab) .
10. If the reagent is not registered, proceed to reagent registration.
11. If the cassette is an open cassette, check for the cassette registration in Inventory > Open
Cassette (tab) .
12. Perform a barcode scan.
See also:
■ Reagent, p.308
■ To Register an Open Cassette, p.94
2.2.2. Alarms on Cassettes
Follow this procedure if a cassette status is different from white or green.
After a barcode scan the instrument displays the cassette status. If color related to the cassette is not
white or green, an action is required by the user.
1. If cassette is displayed in red:

a. Check the cassette because of one of the following reasons:
■ Reagent validity expiration
■ Reagent stability expiration
■ Reagent quantity not specified
■ Cassette empty
b. Check the stability expiration date on the cassette.
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c. Press the red circle corresponding to the cassette.

A window displays cassette's information. Check for the cassette volume and validity
expiration date.
d. If validity or stability date is expired, replace the cassette by a new one.

e. Register cassette volume if necessary in Main menu > Services > System Configuration >
Reagent (tab) .
f. If the cassette is empty, change the cassette or if it is a refillable cassette refill it and press
Volume Reset from the Reagent Tray screen ( Inventory > Reagent Tray (tab) ).
2. If cassette is displayed in orange, reagent volume is low (less than 10%).

a. If using an open cassette, refill the cassette and press Volume Reset from the Reagent Tray
screen ( Inventory > Reagent Tray (tab) ).
b. If using close cassettes, physically check the cassette and replace if necessary.
3. Perform a barcode scan in Inventory > Reagent Tray (tab) .
See also:
■ Reagent, p.308
2.2.3. Alarms on Samples
Follow this procedure if a sample from the sample tray representation (main screen)
displays a question mark.
Tubes flagged with a question mark concern samples registered with a barcode which have not been
detected by the instrument. Tubes are identified by the instrument during initialization at the beginning
of the measurements.

3. Remove the sample tray.
4. If the tube has a barcode, check that the barcode is displayed in the reading window on the
outside area of the sample tray.
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5. If the tube has a barcode, check the barcode displayed on the tube and compare with the one
registered in the worklist.
6. If the barcode sticker is dirty or show sign of condensation, clean it and dry it with a soft paper
towel.
7. Check the barcode label type used on the tube with label specifications of the instrument (see
Description and Technology > Intrument Description > Fluid Storage Module > Sample chapter).
8. Start sample analysis.
If the problem persists, the sample concerned by the identification problem can be
analyzed by deleting the sample from the worklist and doing a manual registration.
See also:
■ Sample, p.310
2.2.4. Alarms on Water and Waste Tanks
Follow this procedure if an alarm concerning water volume or waste tank is triggered.
1. If the alarm "Low system water volume" is triggered:

a. Check the water tank.
b. If necessary fill the water tank.
c. Check that the water tank is positioned at the same level as the instrument.
d. Check that there is no loop on the silicon tube between the water tank and the instrument.
e. Check the water tank sensor.
f. Check the liquid level sensor connector on the left-hand side of the instrument.
2. If the alarm "Waste tank over capacity" is triggered:

a. Check the waste tank.
b. If necessary empty the waste tank.

disposal.
c. Check that the waste tank is located below the instrument.

d. Check that there is no loop on the silicon tube between the waste tank and the instrument.
e. Check the waste tank sensor.
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2.2.5. Light Stability Problems
Follow this procedure if an alarm on light stability problems is triggered.
If the instrument encounters a light stability problem, the alarm "Automatic gain adjustment failed" is
triggered.
Perform lamp replacement as described in the maintenance procedures (see Maintenance and
Troubleshooting > Maintenance > Other Procedures > To Replace the Lamp chapter).
See also:
■ To Replace the Lamp, p.230
2.2.6. Temperature Problems
Follow this procedure if the correct temperature range is not reached in the Sample and
Reagent Container Unit (SRCU) or in the Incubation Reaction Unit (IRU).
Access: Main menu > Services > Customer Services > Performance (tab)
■ SRCU temperature should be between 8°C and 15°C.

■ IRU temperature should be 37°C ± 0.3°C.
1. Check that the room temperature fulfills operational conditions specified in the installation chapter
(see Introduction > Operational Conditions > Installation chapter).
4. Open the Performance screen ( Main menu > Services > Customer Services > Performance
(tab) ).
5. Check SRCU and IRU temperatures in the Performance screen.
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1 = IRU's
temperature
over the last
10 minutes
2 = current
IRU's
temperature
3 = current
SRCU's
temperature
The Performance screen displays live temperatures from the SRCU and IRU.
Temperature in the incubation and reaction unit (IRU) is displayed by two detectors
(orange and red).
The temperature is displayed as a graph only for engineers (EL).
6. Wait a few minutes and check if the temperature moves to its normal operational range.
See also:
■ Performance, p.247
■ Installation, p.19
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2.3. Result Problems
Follow these procedures if calibration, control or patient results are flagged with analytical
alarms.
2.3.1. Result Problems on All Tests and All Samples
Follow this procedure if result problems are detected on all tests and on any sample.
1. If the water from the water tank has been changed:

a. Check that the end of the tubing is at the bottom of the tank.
b. Open the Sequence screen: Main menu > Services > Customer Services > Sequence
(tab) .
c. Type 5 next to the Prime button.
d. Press Prime to fill the tubing.
2. If ISE solutions have been changed and the reproducibility problems concern ISE results, perform
an ISE prime to fill the tubing as described in the maintenance chapter (see Maintenance and
Troubleshooting > Maintenance > Monthly Procedures > ISE Solutions chapter).
3. If the instrument has not been used for more than one day perform a prime to fill the tubing:
a. Open the Sequence screen: Main menu > Services > Customer Services > Sequence
(tab) .
b. Type 5 next to the Prime button.
c. Press Prime to fill the tubing.
4. Physically check the probe.

5. If the probe is bent, change it as described in the maintenance chapter (see Maintenance and
Troubleshooting > Maintenance > Yearly Procedures > Probe Replacement chapter).
6. If probe clogging is suspected, proceed to the probe unblocking as described in the maintenance
chapter (see Maintenance and Troubleshooting > Maintenance > Other Procedures > Probe
Unblocking chapter).
7. Check the syringe plunger tips work hours in Main menu > Services > Customer Services >
Workhour (tab) .
8. If necessary, change the syringe plunger tips.
9. Check the Alarm screen.
10. If a software alarm concerning the Incubation Reaction Unit (IRU) temperature (6520/6521) is
displayed refer to the troubleshooting chapter concerning temperature problems (see Maintenance
and Troubleshooting > Troubleshooting > Analysis Cycle Problems > Temperature Problems
chapter).
11. Perform a precision test as described in the maintenance chapter (see Maintenance and
Troubleshooting > Maintenance > Other Procedures > Precision Test (T1) chapter).
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See also:
■ To Replace the Probe, p.219
■ To Unblock the Probe, p.227
■ Temperature Problems, p.257
2.3.2. Result Problems on a Specific Test
Follow this procedure if results are flagged with an error for all results from a specific test.
1. Check that reagents or diluents have no bubbles.

2. If any bubbles:
a. Remove the bubbles.
b. Rerun the tests.
3. Check the preparatory procedures of the solutions.

4. Check that the appropriate diluent or distilled water of quality has been used.
5. Check the validity of the solutions in the Inventory screen.
6. If the validity has expired, change the solution for a new one.
7. Check the on board stability of the solutions in the Inventory screen.
8. If the stability has expired, change the solution for a new one.
9. Check the lot number of the reagent:
a. Open the Inventory screen ( Inventory > Inventory (tab) ).
b. Check the lot number of the reagent.
c. Open the Calibration screen ( Main menu > Calibration > Calibration ).
d. Check that the calibration has been performed with the same reagent lot number than the
cassette on board.
e. If not run a calibration with the new reagents.
10. Check control results with the new reagents.

11. If any error on control, rerun a calibration and the controls.
12. If the problem persists change the reagents and diluents and run a calibration and the controls.
See also:
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2.3.3. Result Problems on a Specific Sample
2.3.3.1. Calibration Problems
Follow these procedures to solve calibration problems.
Access: Main menu > Calibration > Calibration (tab)
Before any investigation check the lot number of the calibrator and the target values registered in the
Calibration screen.
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CALIBRATION PROBLEM ACTION
User Manual
Ref: RAB274BEN
YES YES
ALARM ON THE BLANK REAGENT BUBBLES REMOVE BUBBLES
NO NO
YES YES
FRESH REAGENT OPEN CASSETTE CLEAN CASSETTE
NO NO CHECK WATER QUALITY
RUN T1
CHECK MAINTENANCE
USE NEW REAGENT
YES
CALIBRATOR BUBBLES REMOVE BUBBLES
YES YES YES
ALARM ON DUPLICATION WELL-MIXED CALIBRATOR FRESH CALIBRATOR
NO NO NO
USE NEW CALIBRATOR

YES MIX CALIBRATOR
ANALYTICAL ALARM
REMOVE BUBBLES
NO
Troubleshooting
RUN CONTROL
262
Troubleshooting
See also:
2.3.3.2. Control Problems
Follow these procedures if controls are flagged with an error.
1. Check the lot number of the control registered in the Calibration screen before any investigation
( Main menu > Calibration > QC Registration (tab) ).
2. Check the target values registered in the Calibration screen ( Main menu > Calibration > QC
Setting (tab) ).
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Ref: RAB274BEN
CONTROL PROBLEM ACTION
CHECK APPLICATION
YES YES YES YES
SAME RESULT ON RERUN NEW CALIBRATION NEW CONTROL NEW REAGENT CHECK UNIT
RUN T1
NO NO NO NO
CHECK MAINTENANCE
USE NEW REAGENT
USE NEW CONTROL
VERIFY CALIBRATOR POSITION
VERIFY CONTROL POSITION
RERUN CALIBRATION
YES YES RUN T1
WELL-MIXED CONTROL VOLUME IN SAMPLE CUP OK

CHECK MAINTENANCE
NO NO
USE NEW SAMPLE CUP
MIX CONTROL
REMOVE BUBBLES
Troubleshooting
RECONSTITUTE NEW CONTROL
264
Troubleshooting
See also:
2.3.3.3. Patient Problems
Follow these procedures if patient results are flagged.
Before any investigation, check visually the sample aspect and volume.
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Ref: RAB274BEN
PATIENT PROBLEM ACTION
YES YES YES YES
SAME RESULT ON RERUN APPLICATION OK SAMPLE TYPE OK CONTROL OK CHECK PATIENT HISTORY
NO NO NO NO
RERUN CALIBRATION
RERUN CONTROL
CHECK REAGENT NOTICE
CHECK APPLICATION
CHECK UNIT
YES YES CHECK MAINTENANCE
SAMPLE WITHOUT FIBRIN VOLUME IN SAMPLE TUBE OK
RUN T1
NO NO
USE SAMPLE CUP
CENTRIFUGE CORRECTLY
REMOVE FIBRIN
Troubleshooting
REMOVE BUBBLES
266
Troubleshooting
See also:
■ To Order Calibration and Control, p.100
2.3.3.4. ISE Calibration Problems
Follow these procedures if ISE calibration is flagged with an error.
Before any investigation:
1. Check the correct volume of Standard 1 and reference solutions.

2. Check Standard 1 and reference solutions stability.

Chloride 28 - 53 5.0 - 9.4
Potassium 37 - 67 9.0 - 16.3
Sodium 38 - 65 8.5 - 14.4
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Ref: RAB274BEN
ISE CALIBRATION PROBLEM ACTION
YES
RERUN CALIBRATION OK RUN CONTROL
NO
YES YES YES YES
ENOUGH NEW STD2 SOL. NEW STD1 + REF SOL. PRIME DONE PROBLEM ON ALL ISE CHANGE REF. ELECTRODE
NO NO NO NO
PERFORM ISE MAINTENANCE
CHANGE CONCERNED ELECTRODE
PERFORM 5 ISE PRIME
CHANGE STD1 AND REFERENCE

PERFORM 5 ISE PRIME
RERUN CALIBRATION
CHANGE STD2 SOLUTION
Troubleshooting
RERUN CALIBRATION
268
Troubleshooting
See also:
■ To Check ISE Solutions (Option), p.201
2.3.3.5. ISE Control Problems
Follow these procedures if ISE control results are flagged.
Before any investigation, check ISE calibration validity.
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Ref: RAB274BEN
ISE CONTROL PROBLEM ACTION
YES
RESULTS IN CONFIDENCE RANGE RUN PATIENT
NO
SAME RESULT ON RERUN YES
CHANGE STANDARD 1 (CASSETTE)
ON URINE CONTROL
NO
YES YES YES
SAME RESULT ON RERUN ISE APPLICATION OK PROBLEM ON ALL ISE CHANGE REF. ELECTRODE
NO NO NO ISE CLEANING WITH ETCHING
ISE CLEANING WITH DEPROT.
CHANGE CONCERNED ELECTRODE
CHECK ISE APPLICATION
YES YES RUN T1
WELL-MIXED AND RECONSTITUTED CONTROL VOLUME IN SAMPLE CUP OK
CHECK ISE MAINTENANCE

NO NO
USE NEW SAMPLE CUP
MIX CONTROL
REMOVE BUBBLES
Troubleshooting
RECONSTITUTE NEW CONTROL
270
Troubleshooting
See also:
■ To Clean ISE with Deproteinizer, p.202
■ To Replace ISE Electrodes, p.222
■ To Clean ISE with Etching (Option), p.126
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Alarms
1. Alarm Overview....................................................................................................................274
2. To Save Alarms....................................................................................................................276
3. Alarm Code Principle.........................................................................................................277
4. System Alarms.....................................................................................................................278
5. Sensor List.............................................................................................................................300
6. Error Flags.............................................................................................................................302
7. Error Code for ISE...............................................................................................................305
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Alarm Overview
1. Alarm Overview
Access: Alarm
Alarms concern mechanical problems, electrical problems and software problems. When an error
occurs, the user is warned by the Alarm icon from the toolbar which change from green to red.
Instrument is OK.
Warning message is displayed, sampling and measurements continu.
Instrument has a mechanical, an electrical or a software problem. The instrument stops

sampling.
To display the error description and code, press the Alarm icon or F4 key (keyboard option). The
Alarm screen is displayed.
Alarm explanation and action to undertake are displayed at the bottom of the screen when user clicks
on the concerned alarm.
Using the alarm's error code, user can refer to the user manual list of alarms to also know the action
to undertake.
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Alarms
Alarm Overview
The Alarm screen displays the last alarms. Up to 110 alarms can be displayed. The
Previous Page and the Next Page buttons allow to display the alarms.
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To Save Alarms
2. To Save Alarms
Follow this procedure to save your alarm list content.
Access: Alarm
1. Press the directory button to specifiy the directory where the file will be saved.
2. Press Export to save the alarm content to the specified directory.

The files are saved in .CSV format (spreadsheet program compatible).
Alarm list can be cleared with Clear All button. Before clearing the list, the alarms can be
saved on a specified file.
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Alarm Code Principle
3. Alarm Code Principle
The alarm's code is composed of four digits. First two digits concern the unit identification, last two
digits are assigned to the error's impact on the instrument.
First two digits significance
Instrument's element concerned by the alarm First 2 digits

Software 60 to 72
Probe's rotation movement (PTR) 01
Probe's vertical movement (PTU) 02
Syringe pump for reagent probe (RPP) 03
Syringe pump for sample probe (SPP) 06
Syringe pump of water for probe (WPP) 45
Mixer unit (MIX) 07 - 08
Mixing unit rotary drive unit (MIXR) 46
Incubation Reaction Unit (IRU) 13
Sample and Reagent Container Unit (SRCU) 14
Detector unit (DTR) 15
Cuvette Loading Unit (CLU) 35 - 36 - 37 - 38
Ion Selective Electrodes unit (ISE) 17 - 18
Tank 26
Sensor status 27 - 28 - 29 - 32 - 33 - 38
Temperature 30
Others 51
Last two digits significance
Level Last 2 digits Alarm type Error's impact

1 00 to 49 Emergency stop Emergency stops due to fatal error.
2 50 to 74 Alarm 1 The instrument stops sampling. Measurement continues for
samples already dispensed.
3 75 to 99 Alarm 2 Error message is displayed. Sampling and measurement
continue.
For software alarms the last two digits are not related to error's impact.
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System Alarms
4. System Alarms
The table below allows to identify problems and action required.
The alarms's code related to the problem is found in the Alarm screen: Main menu >
Alarm
Code Level Message Location and Cause Action

System file is not System file cannot be found. Contact customer service section for
0075
recognized. technical support.
PTR origin sensor is still
PTR Drive unit
0102 1 ON after PTR moves from
PTR origin sensor
the origin.
PTR origin sensor is still Nozzle position is out of the
0104 1 OFF after PTR moves to SRCU side normal movable
the origin. area.
0106 1 PTU origin sensor is OFF Rotary drive unit Turn off the power to the analyzer.
while PTR starts rotation. PTR origin sensor Check that PT unit is free to move
within its normal operational range. Re-
0108 1 CLUX safety sensor is initialize analyzer. If fault returns
Positioning between PT and
OFF while PTR starts contact technical support.
CLU CLUX safety sensor
rotation.
0156 2 PTU origin sensor is OFF PT up-and-down mechanism
while PTR starts rotation. PTU upper limit sensor
0158 2 CLUX safety sensor is Positioning between PT and
OFF while PTR starts CLU
rotation. CLUX safety sensor
0201 1 PTU origin sensor is OFF Up-down driving mechanism
while PTU starts descent. Upper origin sensor
0202 1 PTU origin sensor is ON
after PTU moves from the Nozzle position is beyond the
origin. upper limit.
0203 1 PTU origin sensor is ON Up-down driving mechanism
after PTU moves to the Upper origin sensor Turn off the power to the analyzer.
origin. Check that PT unit is free to move
within its normal operational range.
0204 1 Nozzle position is beyond the
Re-initialize analyzer. If fault returns
PTU origin sensor is OFF lower limit.
contact technical support.
after PTU moves to the The nozzle cannot return to its
origin. origin due to an external force.
Upper origin sensor
0205 1 Nozzle position is beyond the
PTU origin sensor is ON
upper limit.
while PTU starts from the
Up-down driving mechanism
non-origin.
Upper origin sensor
0206 1 Turn off the power to the analyzer.
Positional relation between
IRU safety sensor is OFF Check that IRU unit is free to move
IRU and PT
while PTU starts within its normal operational range.
IRU Drive unit
movement. Re-initialize analyzer. If fault returns
IRU Ready position sensor
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System Alarms

0208 1 PTU origin sensor is OFF
PTR Origin sensor
while PTU starts descent
PTR Rotary drive unit
at IRU.
0251 2 PTU origin sensor is OFF
while PTU starts descent
from the origin.
PTU Drive unit
0253 2 PTU origin sensor is
already ON while PTU
moves to the origin.
0255 2 PTU origin sensor is ON
while PTU moves from
the non-origin.
PTU Drive unit Turn off the power to the analyzer.
0257 2 PT Trough Safety Sensor Check that PT unit is free to move
is ON while PTU starts to within its normal operational range.
move at SRCU. Re-initialize analyzer. If fault returns
0259 2 PT nozzle position at the contact technical support.
SRCU Zero-Position SRCU reagent aspiration
Sensor is OFF while PTU point.
starts to move at SRCU. PTU Drive unit
PT Ready position sensor
0260 2 PT Trough Safety Sensor PT positioning at PT trough
is OFF while PTU starts to PTU up-and down mechanism
move at trough. PT trough safety sensor
0261 2 PT nozzle positioning at the
PT Trough Safety Sensor vessel of C wash solution for
is OFF while PTU starts to PT nozzle
move at DET.W. PTU up-and down mechanism
PT trough sensor
0262 2 PT Trough Safety Sensor PT nozzle positioning at ISE
is OFF while PTU starts to PTU up-and down mechanism Turn off the power to the analyzer.
move at ISE. PT trough sensor Check that PT unit is free to move
0263 2 PT nozzle positioning at STAT within its normal operational range.
PT Trough Safety Sensor Re-initialize analyzer. If fault returns
rack
is OFF while PTU starts to
PTU up-and down mechanism contact technical support.
move at STAT.
PT trough sensor
0276 3 Clean the pipette with ethanol. Check
that reagent pipette detection
Reagent shortage mechanism is not jammed up (the
PT crash sensor is ON
Lower limit sensor pipette should move up and down
during reagent liquid level
SRCU Drive unit freely). Move the pipette a few mm by
detect movement.
PTU Drive unit hand, while holding the pipette arm.
Re-initialize. If fault returns, contact
technical support.
0278 3 Abnormal reagent liquid Reagent shortage Confirm that there is enough reagent
level detection. Undetectable of liquid level quantity in reagent bottle installed in
SRCU. When there is enough, check
0279 3
the probe vertical movement in mm
unit by holding pipette arm, and
Hardware abnormal confirm liquid detection mechanism
Liquid level detection sensor of PT is not obstructed.Wipe the
during reagent liquid level
Wrong detection of liquid level pipette probe with alcohol and
detection.
confirm the normal operation by
initialization. If fault returns, contact
technical support.
0280 3 Shortage of wash solution The inventory of the wash solution is
during PT reagent liquid Wash solution shortage less than amount necessary to
level detection. perform special wash.
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System Alarms

0282 3 Check condition of reagent if reagent
Reagent liquid level Reagent shortage has air bubbles. Remove air bubbles.
detection was failed again. Bubbles Re-initialize. If fault returns contact
technical support.
mechanism is not jammed up (the
PT crash sensor is ON Reagent shortage
pipette should move up and down
during sample liquid level Lower limit sensor
freely). Move the pipette a few mm by
detection. PTU Drive unit
hand, while holding the pipette arm.
Re-initialize. If fault returns contact
technical support.
0284 3 Abnormal sample liquid Confirm that there is enough sample
level detection. quantity in sample tube installed in
SRCU. When there is enough, check
0285 3
the probe vertical movement in mm
unit by holding pipette arm, and
Hardware abnormal Sample shortage confirm liquid detection mechanism
during sample liquid level of PT is not obstructed. Wipe the
detection. pipette probe with alcohol and
confirm the normal operation by
initialization. If fault returns, contact
technical support.
0286 3 Check condition of sample if sample
No liquid level detected at has air bubbles. Remove air bubbles.
Sample shortage
sample position. Re-initialize. If fault returns contact
technical support.
0288 3 Check for liquid in cuvette. Re-
No liquid level detected at Undetectable of liquid level
initialize if fault persists contact
IRU position. Liquid level detection sensor
technical support.
mechanism is not jammed up (the
PT crash sensor is ON
pipette should move up and down
while liquid level detection DET.W solution shortage
freely). Move the pipette a few mm by
at DET.W bottle.
hand, while holding the pipette arm.
Re-initialize. If fault returns contact
technical support.
0290 3 Abnormal liquid level Confirm that there is enough solution
detection at DET.W bottle DET.W solution shortage quantity in DET.W bottle. When there
position. is enough, check the probe vertical
movement in mm unit by holding
0291 3
pipette arm, and confirm liquid
Hardware abnormal detection mechanism of PT is not
during DET.W liquid level DET.W solution shortage obstructed. Wipe the pipette probe
detection. with alcohol and confirm the normal
operation by initialization. If fault
returns, contact technical support.
0292 3 Check condition of DET.W if DET.W
No liquid level detected at has air bubbles. Remove air bubbles.
DET.W solution shortage
DET.W position. Re-initialize. If fault returns contact
technical support.
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System Alarms

0293 3 Confirm that there is enough solution
quantityin DET.W bottle. When there
is enough, check the probe vertical
movement in mm unit by holding
Shortage of solution pipette arm, and confirm liquid
during PTU DET.W bottle DET.W solution shortage detection mechanism of PT is not
liquid level detection. obstructed. Wipe the pipette probe
with alcohol and confirm the normal
operation by initialization. If fault
returns, contact technical support.
(Maintenance)
0301 1 RPP origin sensor is OFF
while RPP starts to
aspirate from origin.
0302 1 RPP origin sensor is ON
while RPP moves from
the origin.
RPP Drive unit
0303 1 RPP origin sensor is Check RPP unit is free to move within
Upper origin sensor
already ON while RPP its normal operational range.
RPP Piping section
moves to the origin Re-initialize analyzer. If fault returns
Solenoid valve
(totally injection). contact technical support.
Syringe tip
0304 1 RPP origin sensor is OFF
while RPP moves to the
origin.
0305 1 RPP origin sensor is ON
during RPP moves from
non-origin.
PT Trough Safety Sensor PTR Drive unit Check that PT unit is free to move
is OFF while RPP moves PTR Origin sensor within its normal operational range.
to the origin. PT trough safety sensor Re-initialize analyzer. If fault returns
0351 2 RPP Drive unit
Check RPP unit is free to move within
RPP origin sensor is OFF RPP Piping section
its normal operational range. Re-
while RPP starts to Solenoid valve
initialize analyzer. If fault returns
aspirate from origin. Upper origin sensor
Syringe tip
0352 2 Clean the PT probe with the probe
PT Probe is clogged.
cleaning jig.
0353 2 RPP origin sensor is
already ON while RPP RPP Drive unit
Check RPP unit is free to move within
moves to the origin. RPP Upper origin sensor
RPP Piping section
0355 2 RPP origin sensor is ON initialize analyzer. If fault returns
Solenoid valve
while RPP moves from contact technical support.
Syringe tip
the non-origin.
is OFF while RPP moves PTR Origin sensor within its normal operational range.
to the origin. PT Trough safety sensor Re-initialize analyzer. If fault returns
User Manual 281

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Alarms
System Alarms

0601 1 SPP origin sensor is OFF
while SPP starts to
aspirate at the origin.
0602 1 SPP origin sensor is ON
after SPP moves from the
origin.
SPP Drive unit
Check SPP unit is free to move within
0603 1 SPP origin sensor is SPP Upper origin sensor
its normal operational range.
already ON while SPP Solenoid valve
Re-initialize analyzer. If fault returns
moves from the origin. SPP Piping section
Syringe tip
0604 1 SPP origin sensor is OFF
after SPP moves to the
origin.
0605 1 SPP origin sensor is ON
after SPP moves from the
origin.
0606 1 PT Trough Safety Sensor PTR Drive unit
is OFF while SPP moves PTR Origin sensor Turn off the power to the analyzer.
to the origin. PT Trough safety sensor Check that PT unit is free to move
0607 1 SRCU Zero-Position PTR Drive unit Re-initialize analyzer. If fault returns
Sensor is ON while SPP PTR Origin sensor contact technical support.
moves to the origin. PT Position sensor
0651 2 SPP Drive unit
SPP origin sensor is OFF SPP Piping section
while SPP starts to Solenoid valve
aspirate at the origin. Upper origin sensor
Syringe tip
PT Probe is clogged.
cleaning jig.
0653 2 SPP origin sensor is
already ON while SPP RPP Drive unit
moves from the origin. RPP Upper origin sensor
its normal operational range.
RPP Piping section
0655 2 SPP origin sensor is ON Re-initialize analyzer. If fault returns
Solenoid valve
while SPP moves from contact technical support.
Syringe tip
non-origin.
0656 2 PT Trough Safety Sensor PTR Drive unit
is OFF while SPP moves PTR Origin sensor Turn off the power to the analyzer.
to the origin. PT Trough safety sensor Check that PT unit is free to move
0657 2 SRCU Zero-Position PT nozzle is out of SRCU Re-initialize analyzer. If fault returns
Sensor is ON while SPP PTR driving mechanism contact technical support.
moves to the origin. PT_SRCU safety sensor
0701 1 Turn off the power, and verify if the
IRU Unit can move smoothly within its
normal movable area.
IRU safety sensor is OFF
IRU Rotary drive unit Reinitialize the analyzer, and check if
before initiation of MXS
IRU Safety sensor it recovers correctly.
reagent mix.
If you still have an error, contact
customer service section for technical
support.
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System Alarms

0702 1 MXR origin sensor is OFF
MXR Origin sensor
MXR Rotary drive unit
reagent mix.
0703 1 MIX safety sensor is OFF
MIX Trough safety sensor
MIXR Rotary drive unit
reagent mix
0706 1 MXU origin sensor is ON
MIXU Drive unit
before MXS reagent mix.
0751 2 MXR origin sensor is ON
MIXR Drive unit
Rotation origin sensor
wash mix.
MIXR Drive unit
MIX Trough safety sensor
wash mix.
0753 2 MXU origin sensor is ON
MIXR Drive unit
Rotation origin sensor
wash mix. Turn off the power to the analyzer.
Check that MIX unit is free to move
0801 1 MXU origin sensor is OFF
MIXU Drive unit within its normal operational range. Re-
while MXU movement
MIXU Upper origin sensor initialize analyzer. If fault returns
from its origin.
0802 1 MXU origin position
MIXU Drive unit
sensor is ON after MXU
MIXU Upper origin sensor
moves from its origin.
0803 1 MIX unit is in out of movable
MXU origin sensor is
area
already ON before MXU is
MIXU Drive unit
back to the origin.
0804 1 Mixing stirrer cannot return to
MXU origin sensor is OFF its origin due to an external
after MXU is back to the force.
origin. MIXU Drive unit
0805 1 Mixing stirrer cannot return to
MXU origin sensor is ON its origin due to an external
while MXU moves from force.
the non-origin. MIXU Drive unit
Origin sensor
IRU Drive unit
before initiation of MXU within its normal operational range. Re-
IRU safety sensor
movement. initialize analyzer. If fault returns
0807 1 MXU origin sensor is OFF MXU Origin sensor
before initiation of MXU MIX Up-down driving
movement. mechanism
Turn off the power to the analyzer.
MIX_TS Sensor Check that MIX unit is free to move
MIX Rotary drive unit within its normal operational range. Re-
movement.
0809 1 MXR origin position contact technical support.
MIXR Origin sensor
sensor is ON before
MIX rotation driving
initiation of MXU
mechanism
movement.
PTU origin position
Check that PT unit is free to move
sensor is OFF before PTU Drive unit
initiation of MXU PTU upper origin sensor
movement.
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Ref: RAB274BEN
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System Alarms

0851 2 MXU origin sensor is OFF MXU Origin sensor
while MXU movement MIX Up-down driving
from the origin. mechanism
0853 2 MXU origin position MXU Origin sensor
sensor is ON before MXU MIX Up-down driving Turn off the power to the analyzer.
moves to its origin. mechanism Check that MIX unit is free to move
0855 2 MXU origin sensor is ON MXU Origin sensor initialize analyzer. If fault returns
while MXU movement MIX Up-down driving contact technical support.
from the origin. mechanism
MIXR Drive unit
before initiation MXU
MIX trough safety sensor
movement.
1301 1 IRU origin sensor is ON
IRU Drive unit
after IRU is moved form Turn off the power to the analyzer.
IRU Origin sensor
its origin position. Check that IRU unit is free to rotate.
1302 1 IRU origin position sensor Re-initialize analyzer. If fault returns
IRU Drive unit contact technical support.
is OFF after IRU moves to
IRU Origin sensor
its origin.
PTR origin sensor is ON PTU Drive unit
Check that PT unit is free to rotate. Re-
and PTU is OFF before PTU Upper origin sensor
IRU rotates. PTR Drive unit
1311 1 MIXR Drive unit Turn off the power to the analyzer.
MIXR origin sensor is ON
MIXR Origin sensor Check that MIX unit is free to rotate.
and MIXU is OFF before
MIXU Drive unit Re-initialize analyzer. If fault returns
IRU rotates.
MIXU Upper origin sensor contact technical support.
CLUZ safety sensor is
CLUZ Drive unit Check that CLU unit is free to rotate.
OFF before initiation of
CLUZ safety sensor Re-initialize analyzer. If fault returns
IRU rotation movement.
1402 1 SRCU origin sensor is ON
after it moves from origin Turn off the power to the analyzer.
position. SRCU Origin sensor Check that SRCU unit is free to
1404 1 SRCU origin sensor is SRCU Drive unit rotate. Re-initialize analyzer. If fault
OFF after SRCU moves to returns contact technical support.
origin position.
PTU origin sensor is OFF PT nozzle cannot return to its
Check that PT unit is free to rotate. Re-
while SRCU starts to origin due to an external force.
rotate. PT Upper origin sensor
1501 1 Communication with Sub CPU is
Program version data not Communication with the DTR electrically incapable. Contact
transferred from Sub CPU. control CPU customer service section for technical
support.
FLT origin sensor is ON
FLT rotation mechanism Check that FLT unit is free to rotate.
after FLT moves from its
FLT origin sensor Re-initialize analyzer. If fault returns
origin.
Absorbance data not Communication with the DTR electrically incapable. Contact
support.
FLT origin sensor is OFF
FLT rotation mechanism Check that FLT unit is free to rotate.
after FLT moves to its
FLT origin sensor Re-initialize analyzer. If fault returns
origin.
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System Alarms

DTR: Unable to receive
Communication with the DTR electrically incapable. Contact
offset voltage from Sub
control CPU customer service section for technical
CPU.
support.
Measured absorbance is
electrically incapable. Contact
too high and outside Halogen Lamp
customer service section for technical
measurable range.
support.
1509 1 Absorbance of Air Blank Measurement value of Air Blank is
is outside of the range Halogen Lamp abnormal. Contact customer service
(abnormal lamp check) section for technical support.
1510 1 Measurement result of Autogain is
Result of Autogain is
Halogen Lamp abnormal. Contact customer service
outside of the range.
section for technical support.
Autogain data not Communication with the DTR electrically incapable. Contact
support.
1578 3 Measured absorbance is Measurement value of Air Blank is
too high and outside Halogen Lamp abnormal. Contact customer service
measurable range. section for technical support.
1775 3 There is no response to
Serum Sample inquiry. ISE Communication error with ISE
1776 3 There is no response to ISE Communication cable module. Contact technical support.
Urine Sample inquiry.
1777 3 ISE result measurement ISE
Refer to "ISE Module Error Code".
data is not available. ISE Communication cable
1780 3 Malfunction of ISE
module for "Electrode
Exchange" command.
module for "Prime"
command. Possible broken communication or
ISE
poor contact at connectors. If fault
1782 3 Malfunction of ISE ISE Communication cable
returns contact technical support
module for "Cleaning"
command.
module for "Calibration"
command.
1792 3 Liquid level of ISE cleaning solution
Failed to detect ISE Cleaning solution shortage
could not be detected. Set ISE
cleaning solution. Liquid level sensor
cleaning solution
1793 3 Liquid level of Standard II for ISE
Failed to detect Standard Standard II Solution shortage
could not be detected. Set Standard
II for ISE. Liquid level sensor
II Solution.
1875 3 Failed to detect wash Liquid surface was not detected by
solution for PT special Liquid level sensor PT nozzle special wash. Set the wash
wash. solution.
1876 3 Unevenness of the X-axis, Unevenness of the X-axis, which
Check the mounting position
required at CLU adjusted at CLU positioning revise, is
of the cuvette rack mount unit
positioning revise, is beyond the limit. Confirm machine
(CM) of the direction of X.
beyond the limit. adjustment of rack mounting position.
1877 3 Unevenness of the Y-axis, Unevenness of the Y-axis, which
(CM) of the direction of Y.
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1878 3 Unevenness of the Z-axis, Unevenness of the Z-axis, which
(CM) of the direction of Z.
1880 3 Revised value of DTR position is
Machine assembly error is
Check the mounting position outside of the specified range.
beyond the limit in DTR
of DTR. Confirm machine adjustment of rack
position adjustment.
mounting position.
1881 3 Liquid detection error in Failed to detect wash solution due to
Cleaning solution shortage
absorption at solution the shortage of undiluted solution. Set
Sensor
compound. the wash solution.
1882 3 Failed to satisfy the specified
Liquid detection error in compound volume due to the
System water shortage
volume check after shortage of system water. Check
Sensor
compounding solution. residual amount of system water in
the tank.
1883 3 Residual liquid in the
Liquid detection in the DET.W bottle
DET.W bottle is detected Check the remaining liquid in
at solution compounding. Make the
at the volume check of the DET.W bottle.
bottle empty.
compound solution.
1884 3 Check whether DET.W bottle
DET.W bottle is not
exists or not in the suitable The DET.W bottle is not set at
detected when
position. solution compounding. Set the bottle.
compounding the solution.
Sensor
1975 3 ISE Unit Contact customer service section for
ISE cummunication failure.
ISE communication cable technical support.
1976 3 Contact customer service section for
ISE hardware abnormal. ISE Unit
technical support.
1977 3 Contact customer service section for
ISE system abnormal. ISE Unit
technical support.
1978 3 ISE module is under ISE Unit(under immeasureable
Perform ISE calibration.
unmeasurable state. condition)
1979 3 Two poor calibrations in ISE Unit (1-point calibration
Perform ISE calibration.
ISE module failure)
1980 3 Failed to detect liquid Failed to detect the liquid level of ISE
ISE Cleaning solution shortage
level of ISE Cleaning Cleaning solution. Install the ISE
Liquid level detection sensor
(under deprot process). Cleaning solution.
1981 3 Failed to detect liquid ISE Cleaning solution2 Failed to detect the liquid level of ISE
level of ISE Cleaning shortage Cleaning solution2. Install the ISE
(Etching). Liquid level detection sensor Cleaning solution2.
1982 3 Failed to detect liquid ISE Activation sample Failed to detect the liquid level of ISE
level of ISE Activation shortage Activation sample. Install the ISE
sample. Liquid level detection sensor Activation sample.
1983 3 Failed to detect the liquid level of ISE
Failed to detect liquid Standard II shortage
Standard II solution. Install the ISE
level of ISE Calibration. Liquid level detection sensor.
Standard II solution.
1984 3 ISE is working. ISE Unit (under operation) Retry the failed ISE measurements.
2075 3 The pumping speed Replace with the new tube unit. If
ISE Unit
adjustment is beyond the error still occurs, contact technical
Tube Unit
limit. support.
2076 3 Confirm the remaining quantity of
Cannot detect Standard I
Standard I. If no problem on the
at LB sensor.
Standard I Solution shortage quantity, replace with the new reagent.
2077 3 LB1 sensor Perform ISE priming to confirm
Incorrect supplying
whether to detect an error. If the error
quantity of Standard I(LB1)
still occurs, contact technical support.
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System Alarms

2078 3 Check the quantity of Standard II
Cannot detect Standard II remains more than 500uL. If it
at LB sensor. becomes below, refill more than
Standard II Solution shortage 500uL and perform re-calibration.
LB1 sensor
2079 3 Incorrect supplying Perform ISE priming to confirm
quantity of Standard II whether to detect an error. If the error
(LB1). still occurs, contact technical support.
2080 3 Check the quantity of the sample
Cannot detect the sample remains more than 500uL. If it
at LB1 sensor. becomes below, refill more than
Sample shortage 500uL and perform re-measurement.
LB1 sensor
quantity of the sample whether to detect an error. If error still
(LB1). occurs, contact technical support.
2082 3 Detects abnormal Perform ISE priming to confirm
condition at LB sensor LB sensor whether to detect an error. If the error
check. still occurs, contact technical support.
2083 3 Rebooting of UI is necessary. If fault
Hardware abnormal. ISE Unit
returns contact technical support.
2084 3 Confirm the remaining quantity of
Cannot detect Standard I Standard I Solution shortage
Standard I. If no problem on the
at LB2 sensor. LB2 sensor
quantity, replace with the new reagent.
quantity of Standard I LB2 sensor whether to detect an error. If the error
(LB2). still occurs, contact technical support.
2086 3 Check the quantity of Standard II
Cannot detect Standard II remains more than 500uL. If it
Standard II Solution shortage 500uL and perform re-calibration.
LB2 sensor
2087 3 Perform ISE priming to confirm
Incorrect supplying
whether to detect an error. If the error
quantity of Solution (LB2).
still occurs, contact technical support.
2088 3 Check the quantity of the sample
Cannot detect the sample remains more than 500uL. If it
Sample shortage 500uL and perform re-measurement.
LB2 sensor
quantity of the sample. whether to detect an error. If error still
(LB2) occurs, contact technical support.
2605 1 Purified water shortage
Low system water volume. Refill tank and prime analyzer.
Sensor
2609 1 Waste tank for wastewater is
Waste tank over capacity. Empty waste tank.
full.
Sensor
full.
Sensor
full.
2701 1 Analyzer top cover is not
Case cover is open. closed properly. Close case cover.
Lid sensor
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System Alarms

2702 1 SRCU lid is not closed
SRCU lid is open. properly. Close SCRU lid.
Lid sensor
2703 1 STAT cover is not closed
STAT cover is open. properly. Close STAT cover.
Cover sensor
2704 1 Analyzer top cover is open. Close case cover.
24 Volt power supply is
OFF. 24 V power monitoring sensor
Check the Sensor screen.
for SRCU
2720 1 Trough chamber
overflows. PT trough Inability of drain system. Check drain
MIX trough line located at right-hand side of
2781 3 Trough chamber Sensor cabinet.
overflows.
2801 1 Water leakage is detected
Water leakage at PT trough
at trough1.
Water leakage at MIX trough
at trough2.
at trough1.
Water leakage at MIX trough
at trough2.
at trough1.
Water leakage at MIX trough Contact customer service section for
at trough2.
technical support.
2951 2 Power supply fan failure. Power supply fan
2956 2 Chassis fan failure. Chassis fan
2958 2 DTR fan failure. DTR fan
2975 3 Power supply fan failure. Power supply fan
2980 3 Chassis fan failure during. Cabinet fan
2982 3 DTR fan failure. DTR fan
2984 3 SRCU peltier 1 failure.
Peltier fan
2985 3 SRCU peltier 2 failure.
2987 3 CPU fan failure. CPU fan
3051 2 IRU Heater
IRU Slip ring
IRU temperature is less IRU Temperature should stabilize
IRU_HT1 PC board
than 35 degrees. between 35 to 39 degrees during
IRU_HT2 PC board
MAIN-DRV PC board measurement. Check IRU
temperature on temperature monitor
3052 2 IRU Slip ring in Maintenance screen. Contact
IRU temperature is more IRU_HT1 PC board technical support.
than 39 degrees. IRU_HT2 PC board
MAIN-DRV PC board
3053 2 SRCU temperature is SRCU Temperature should stabilize
more than 15 degrees. SRCU Peltier between 2 to 15 degrees during
SRCU Peltier fan measurement. Check IRU
3054 2
SRCU temperature is less SRCU-DRV PC board temperature on temperature monitor
than 2 degrees. MAIN-DRV PC board in Maintenance screen. Contact
technical support.
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System Alarms

3055 2 IRU Heater
IRU abnormal IRU Slip ring Check IRU temperature during
temperature during IRU_HT1 PC board standby mode on the Maintenance
measurement. IRU_HT2 PC board screen and contact technical support.
MAIN-DRV PC board
3056 2 SRCU Peltier
SRCU abnormal Check SRCU temperature during
SRCU Peltier fan
temperature during standby mode on the Maintenance
SRCU-DRV PC board
measurement. screen and contact technical support.
MAIN-DRV PC board
3075 2 IRU Heater
IRU Slip ring Check IRU temperature during
IRU abnormal
IRU_HT1 PC board standby mode on the Maintenance
temperature.
IRU_HT2 PC board screen and contact technical support.
MAIN-DRV PC board
3078 2 SRCU Peltier
Check SRCU temperature during
SRCU abnormal SRCU Peltier fan
standby mode on the Maintenance
temperature. SRCU-DRV PC board
screen and contact technical support.
MAIN-DRV PC board
3201 1 When error occurred not pushing the
button, turn off the power, and
confirm pressing of the button is
Detected emergency stop Push button switch for
smooth. Then perform initialization
request. emergency stop
again, and confirm normal operation.
If errors repeat, contact customer
service.
3301 1 Cuvette drop detected
before disposal to cuvette CATCH sensor
waste. Contact customer service section for
3302 1 Cuvette drop detected technical support.
before placement to IRU CATCH sensor
turn table.
3502 1 CLUZ origin sensor is ON
after CLUX moves from
the origin. CLUX origin sensor Turn off the power to the analyzer.
3504 1 CLUX origin sensor is CLUX driving mechanism Check that CLU unit is free to move
OFF after CLUX moves to within its normal operational range. Re-
the origin. initialize analyzer. If fault returns
3506 1 CLUX origin position
CLUZ origin sensor
sensor is off before CLUX
CLUZ driving mechanism
movement.
3507 1 Cuvette waste container
Removal of the cuvette waste
sensor is OFF after CLUX Not setting the dust box
container was detected. Install the
moves to disposal DUST_POS sensor
cuvette waste container.
position.
3551 2 CLUX origin sensor is
CLUX origin sensor Turn off the power to the analyzer.
OFF while CLUX
CLUX driving mechanism Check that CLU unit is free to move
movement from origin.
3556 2 CLUZ origin sensor is initialize analyzer. If fault returns
CLUZ origin sensor
OFF before CLUX contact technical support.
movement.
PTR origin sensor is ON Check that PT unit is free to move
PTR origin sensor
during CLUX moves to within its normal operational range. Re-
PT rotating driving mechanism
tray position. initialize analyzer. If fault returns
User Manual 289

Ref: RAB274BEN
Alarms
System Alarms

MIXR origin sensor is ON MIXR origin sensor Check that MIX unit is free to move
during CLUX moves to MIX rotating driving within its normal operational range. Re-
tray position. mechanism initialize analyzer. If fault returns
3559 2 Tray 1 position sensor is
Not setting the Cuvette rack 1 Removal of the cuvette rack 1was
OFF after CLUX moves to
CR1 sensor detected. Install the cuvette rack 1.
Tray 1 position.
Not setting the Cuvette rack 2 Removal of the cuvette rack 2 was
OFF after CLUX moves to
Tray 2 position.
sensor is OFF after CLUX Not setting the dust box
moves to disposal DUST_POS sensor
position.
3602 1 CLUY origin sensor is ON CLUY origin sensor
after CLUY moves from CLU back-and-fore driving
the origin. mechanism
3604 1 CLUZ origin sensor
CLUY origin sensor is Check that CLU unit is free to move
OFF after CLUY moves to within its normal operational range. Re-
CLUX origin sensor
the origin. initialize analyzer. If fault returns
CLUX driving mechanism
3606 1 CLUZ origin sensor is
CLUZ origin sensor
OFF while CLUY
movement.
sensor is OFF during Not setting the dust box
CLUY moves to disposal DUST_POS sensor
Cuvette waste container.
position.
3651 2 CLUY origin sensor is
CLUY origin sensor Turn off the power to the analyzer.
OFF while CLUY
CLUY driving mechanism Check that CLU unit is free to move
movement from the origin.
3656 2 CLUZ origin sensor is initialize analyzer. If fault returns
CLUZ origin sensor
OFF while CLUY contact technical support.
Not setting the Cuvette rack 1 Removal of the cuvette rack 1was
OFF during CLUY moves
to Tray 1.
Not setting the Cuvette rack 2 Removal of the cuvette rack 2 was
OFF during CLUY moves
to Tray 2.
3661 2 Dust box sensor is off Removal of the cuvette waste
Not setting the dust box
after CLUY moves to container was detected. Install the
DUST_POS sensor
disposal position. cuvette waste container.
3662 2 The disposal cuvettes of
Check the main menu of the Execute disposal of cuvettes in the
the cuvette waste
user interface. cuvette waste container.
container exceed the limit.
3663 2 Check the main menu of the
No cuvette is remaining. Install cuvettes.
user interface.
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OFF after CLUZ moves
from the origin.
after CLUZ moves from
the origin.
3703 1 CLUZ origin sensor is ON Check that CLU unit is free to move
CLUZ origin sensor
before CLUZ moves to its within its normal operational range. Re-
origin. initialize analyzer. If fault returns
OFF after CLUZ moves to
the origin.
while CLUZ movement
from non-origin.
3706 1 Turn off the power, and remove the
Initialization is going to be
CLU cannot be cuvette by hand. Perform initialization
executed with holding the
initialization due to again, and confirm the operation. If
cuvette in the cuvette catcher.
cuvette disposal failure. error repeats, contact technical
Stopping the CLU
support.
CLUZ down to disposal DUST_POS sensor
position.
3708 1 CATCH driving mechanism
CATCH lower limit sensor
CLU Lower Limit Sensor
CLUX sensor
is ON during CLU
CLUY driving mechanism
downward movement.
CLUY sensor
CLUZ sensor
3710 1 IRU safety sensor is OFF Turn off the power to the analyzer.
IRU safety sensor
while CLUZ upward Check that CLU unit is free to move
IRU driving mechanism
movement from IRU. within its normal operational range. Re-
OFF while CLUY
movement from its origin.
CLUZ origin sensor
before CLUZ moves to
the origin.
while CLUZ movement
from non-origin.
CLUZ down to disposal DUST_POS sensor
position.
IRU safety sensor
during CLUZ down to IRU within its normal operational range. Re-
IRU driving mechanism
position. initialize analyzer. If fault returns
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Ref: RAB274BEN
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System Alarms

3764 2 Catch senor is ON after
CLUZ places cuvette on
IRU. CATCH sensor
3765 2 Catch sensor is ON after
CLUZ cuvette disposal.
3766 2 CLU catch driving mechanism
CLU Lower Limit Sensor CATCH lower limit sensor
is ON during move down CLUC origin sensor
to take cuvette. CLUZ driving mechanism
CLUZ origin sensor
3776 3 Catch sensor is ON after
CLUZ places cuvette on
IRU. CATCH sensor
3778 3 Catch sensor is ON after Turn off the power to the analyzer.
disposal of cuvette. Check that CLU unit is free to move
3801 1 CLUC origin sensor is initialize analyzer. If fault returns
OFF while CLUC contact technical support.
3802 1 CLUC origin sensor is ON
after CLUC moves from
the origin.
CLUC origin sensor
before CLUC moves to
CLUC driving mechanism
the origin.
3804 1 CLUC origin sensor is
OFF after CLUC moves to
the origin.
while CLUC moves from
the non-origin.
CLU catch sensor is ON Check that CLU unit is free to move
CATCH sensor
after completion of within its normal operational range. Re-
initialization movement. initialize analyzer. If fault returns
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System Alarms

3807 1 CATCH down limit sensor
CLU Lower Limit Sensor
CLUC origin sensor
is ON.
CLUZ driving sensor
CLUZ origin sensor
3808 1 CATCH sensor
Lost cuvette when taking CLUC driving mechanism
out disposal cuvette from CLUC origin sensor
IRU. CLUZ driving mechanism
CLUZ origin sensor
after CLUC moves to the
CLUC origin sensor
origin.
3854 2 Catch sensor is ON while
cuvette catch movement.
3855 2 Catch sensor is ON while
cuvette catch movement. CATCH sensor
3856 2 Catch sensor is OFF after CLUC origin sensor Turn off the power to the analyzer.
CLUZ cuvette catch CLUZ driving mechanism Check that CLU unit is free to move
movement. CLUZ origin sensor within its normal operational range. Re-
3857 2 Catch sensor is OFF after
cuvette catch movement
at IRU.
3858 2 Check the settings of first
cuvette position for next
taking at cuvette rack in the
main menu from the user
interface.
No cuvette in position of Check whether cuvette exists
next taking at cuvette or not at the cuvette rack.
rack when retry. CLUX driving mechanism
CLUX origin sensor
CLUY driving mechanism
CLUY origin sensor
CLUZ origin sensor
3859 2 CLU Lower Limit Sensor
is ON during downward CLUC driving mechanism
movement to cuvette CATCH lower limit sensor
waste.
3860 1 The latch circuit of
Contact customer service section for
CATCH sensor is CNT-IBM board
technical support.
abnormal.
3875 3 Catch sensor is OFF after
CLUZ cuvette catch CATCH sensor Turn off the power to the analyzer.
movement. CLUC driving mechanism Check that CLU unit is free to move
CLUC origin sensor within its normal operational range. Re-
3876 3 Catch sensor is OFF after CLUZ driving mechanism initialize analyzer. If fault returns
CLUZ cuvette catch CLUZ origin sensor contact technical support.
movement.
3877 3 Check whether cuvette exists
or not at the cuvette rack.
There is no cuvette at specified
No cuvette in position of CLUX origin sensor
position. Specify the correct position
next taking at cuvette rack. CLUY driving mechanism
of the cuvette.
CLUY origin sensor
CLIZ origin sensor
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System Alarms

4501 1 WPP origin sensor is OFF
while starts to aspirate
from WPP origin.
4502 1 WPP origin sensor is ON
after WPP moves from
the origin.
WPP Drive unit
Check WPP unit is free to move
4503 1 WPP origin sensor is ON WPP Upper origin sensor
before WPP moves to the WPP Piping section
origin. Solenoid valve
Syringe tip
4504 1 WPP origin sensor is OFF
after WPP moves to the
origin.
while WPP movement
from non-origin.
is OFF while WPP WPP Upper origin sensor within its normal operational range. Re-
movement to its origin. PT trough safety sensor initialize analyzer. If fault returns
4551 2 WPP Drive unit
Check WPP unit is free to move
WPP origin sensor is OFF WPP Upper origin sensor
while starts to aspirate WPP Piping section
from WPP origin. Solenoid valve
Syringe tip
PT probe is clogged.
cleaning jig.
before WPP moves to the WPP Drive unit Check WPP unit is free to move
origin. WPP Upper origin sensor
WPP Piping section
4555 2 WPP origin sensor is ON Solenoid valve initialize analyzer. If fault returns
while WPP movement contact technical support.
Syringe tip
from non-origin.
is OFF while WPP PTR origin sensor within its normal operational range. Re-
movement to its origin. PT trough safety sensor initialize analyzer. If fault returns
4601 1 Mix unit cannot return to its
origin due to an external force.
MXU origin sensor is OFF
MXU Upper origin sensor
while MXR movement.
MIX Up-down driving
mechanism
Check that MIX unit is free to move
MXR origin sensor is OFF origin due to an external force
while MXR movement. MXR Origin sensor
MIX Rotary drive unit
MIXR origin sensor is ON origin due to an external force.
after MIXR moves from Rotation of MIX driving
the origin. mechanism
MIXR origin sensor
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4605 1 There may be abnormality
CLUX safety sensor is
between MIX and CLU.
OFF after MIXR moves to Turn off the power to the analyzer.
CLUX Drive unit
its origin position. Check that CLU unit is free to move
CLUX safety sensor
4655 2 CLUX Drive unit initialize analyzer. If fault returns
CLUX safety sensor is
MXU Origin sensor contact technical support.
OFF after MIXR moves to
MIX Up-down driving
its origin position.
mechanism
5001 1 Wipe the reading window of the
Reagent barcode reader; barcode reader with alcohol.If you still
Barcode reader
Initialization error. have an error, contact our customer
service section for technical support.
5175 3 Communication failure.
5176 3 Transmission error in
Connecting part of Sub-CPU
transferring write-control Contact customer service section for
Occurring the communication
program size occurred. technical support.
problem
5177 3 Writing Control program
transfer failure.
5178 3 Sub CPU writing-control program /
No program file in sysboot/ There is no file in the sysboot/ sysboot/system/SH_Loader_Ca90.bin
system file. system folder. is not found. Contact customer
service section for technical support.
5179 3 Writing Control program
transfer failure Connecting part of Sub CPU
Contact customer service section for
5180 3 Communication failure Occurring the communication
technical support.
during transfer of boot problem.
program.
5181 3 Sub CPU execution program sysboot/
No boot program found in There is no file in the sysboot/ system/subcpu.run is not found.
sysboot/system file. system folder. Contact customer service section for
technical support.
6002 Concentration calculation Concentration calibration from measured results not possible. Check
error. the settings in the calibration screen are correct.
6003 Full calibration has failed. Check the concentration values at the
Full calibration failed.
calibration screen. Check calibrator set in the sample tray of SRCU.
6004 Full one point or two point calibration has failed. Check the calibration
Full, one point or 2-point
concentration values at the calibration screen. Check the calibrator
calibration failed.
set in the sample tray of SRCU.
6005 Printer output failed. Check printer cable connection and printer is in a ready condition.
6008 Invalid standard sample Found standard without concentration value. Input the concentration
found. value.
6009 Concentration information Concentration value is not defined. Check the concentration values
not available. for the necessary number of calibrators at the calibration screen.
6010 There are less than 30
Amount of cuvettes for testing are shortage.
good cuvettes and testing
Add the new cuvette rack on the CM (cuvette rack mount unit).
cannot begin.
6011 The message received from mechanical control software is longer
Data reception error.
than maximum allowed data length. Check the software version.
6012 Software interruption occurred at the time of calculation of
Software interrupted.
concentration overflow or division by zero.
6013 Bcc error occurred during
Check the communication setting at system parameters.
host communication.
6014 Time out error occurred
There is no response from the host computer. Check the connection
during host
to host.
communication.
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System Alarms

6015 Re transmission error Reagent blank data has been deleted automatically due to expiration
occurred during host of storage period.Reagent blank data for the selected measurement
communication. has been deleted.Unable to display raw data.
6016 Reagent blank data has been deleted automatically due to expiration
Unable to display raw of storage period.
data. Reagent blank data for the selected measurement has been deleted.
Unable to display raw data.
6030 Database update failure.
6031 Database insertion failure.
There is possible abnormality or failure in database. Contact technical
6032 Database deletion failure. support.
6033 Database Select Open
failure.
6101 Not enough reagent There is not enough inventory of the following reagent to perform
inventory to initiate the run. measurement. Replace reagent bottle. Reagent name, reagent type.
6102 Not enough Calibrant A to Remaining amount of Calibrant A is insufficient. Replace the bottle
perform tests ordered. with new a one.
6103 Possible shortage of
The shortage of reagent remaining is expected to perform tests
reagent to perform tests
ordered. Check the remaining volume of reagent.
ordered.
6104 Sensor has detected an error and the measurement cannot be
Error detected
started. Check the sensor.
6105 Measurement was
completed while STAT Confirm the STAT condition, and start the order if necessary.
remains opening.
6120 Standard has been set for Calibration curve type "Factor" does not require calibration. Check for
“Factor” assay. correct standard or calibration curve settings.
6121 When blank measurement is set to enable reagent blank as S1, other
Only S2 is available for
standard sample than S2 cannot be set. Check for correct settings
the calibration.
and standard set on the analyzer.
6122 When blank measurement is set to enable reagent blank as S1, single
Only S2 is available for
standard sample cannot be set. Check for correct settings and
the calibration.
standard set on the analyzer.
6123 Calibration is performed
due to lack of calibration Check the sample number and method number
curve for method.
6124 Measurement is not
performed due to lack of Check the sample number and method number
calibration curve.
6125 Disagreement of reagent
The lot number of reagents that has been used for calibration must be
lot number used for
used for measurement. Check the reagent bottle for correct lot number.
measurement.
6201~ SRCU bottle barcode
Check label on bottle to ensure it is free from any damage and is
6260 number (1~60) is
clearly displayed in the SRCU slot.
unreadable.
6301~ SRCU bottle number
Barcode has already been used in this analyzer. Use another bottle/
6360 (1~60) has already been
barcode.
assigned.
6401~ Reagent code on SRCU
6460 bottle position number Check reagent is registered under system parameters.
(1~60) is not registered.
6500 The process has been
interrupted due to Contact technical support.
mechanical malfunction.
6501 Automatic gain
Check the halogen lamp. Perform automatic gain adjustment.
adjustment failed.
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System Alarms

6502 Found maintenance parts Check working hour counter for the parts on Work Hour screen in
due exchange. Maintenance menu.
6503 Emergency stop has occurred while attempting to recover from an
Failed to restart the
emergency stop. Check for mechanical interference of modules and
analyzer.
damage to hardware.
6510 Sensor detects the error. Check the sensor and sensor number.
Error detected.
Check the situation.
6520 IRU temperature is less
than 36.5 degrees C. IRU Temperature should be kept between 36.5 to 37.5 degrees C
during measurement. Check the temperature monitor on Mainte-
6521 IRU temperature is more Perform screen and contact technical support.
than 37.5 degrees C.
6522 SRCU temperature is
more than 15 degrees C. SRCU Temperature should be kept between 2 to 15 degrees C during
measurement. Check the temperature monitor on Mainte-Perform
6523 SRCU temperature is less screen and contact technical support.
than 2 degrees C.
6600 Omitted order registration
The following position and sample numbers are not registered as
of position and sample
order. Check order, Position number, Sample number.
numbers.
6601 Measurement is not
performed due to Measurement cannot be performed as duplicate order for a sample
duplicate order for a has been found. Verify the order and Sample number.
sample.
6602 Existing order for a
sample has been Although the order received for a sample has already been registered,
overwritten with new its order is overwritten with new order. Sample No.
order.
6603 Check label on bottle to ensure it is free from any damage and is
Invalid barcode.
clearly displayed in the SRCU slot.
6700 Check printer cable connections and that the printer is in a ready
Printer output failed.
condition.
7001 Existing sample order has
An existing order for a sample has been over written with new orders
been overwritten with new
received from host for the sample. Sample No.
order from host.
7002 Communication error
Communication error has occurred while inquiring order to host.
occurred during order
Check connection to host then retry order inquiry to host.
reception from host.
7003 Communication error
Communication error has occurred while sending results to host.
occurred during result
Check connection to host then retry result transmission to host.
transmission to host.
7004 Received order with short Received order from host for tests without enough reagent inventory
reagent received from for the following sample number and method number. Take corrective
host. action and inquire host for the order. Sample No., Method
7005 Invalid sample number Host has ordered tests for sample type other than normal and
received from host was emergency. The order for the following sample has been deleted.
deleted. Check at host for proper order. Sample No.
7006 Communication error has occurred while sending results to host due
Failed to allocate memory to memory allocation error. Check for proper memory capacity and
for result transmission. terminate any application running on the PC then retry result
transmission to host. If the error repeats, re-booting of PC is required.
7007 Host transmissions retry The host communication protocol may not be set correctly. Check
time over error. the settings at system parameter screen.
7008 Communication error has occurred while sending results to host due
Failed to allocate memory to memory allocation error. Check for proper memory capacity and
for order acquire. terminate any application running on the PC then retry result
transmission to host. If the error repeats, re-booting of PC is required.
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System Alarms

7010 Invalid sample number
Received an order for following sample from host but it has been
received from host was
deleted, as the sample was not registered. Sample No.
deleted.
7011 Error has occurred while acquiring QC data due to memory allocation
Failed to allocate memory
error. Rebooting of PC is necessary. If fault returns contact technical
while acquiring QC data.
support.
7030 Failed to read serum Failed to load serum indices file. The parameter setting file is either
indices setting file. missing or corrupted. Contact technical support.
7051 Received more orders
Received more orders than the maximum sample numbers (1,000) for
from host than the
order registration. Check with the Host.
analyzer can handle.
7052 ISE calibrator B is not ISE calibrator B is not registered. Register ISE calibrator before start
registered. ISE calibration.
7053 ISE wash solution is not ISE wash solution is not registered. Register ISE wash solution before
registered. start ISE cleaning.
7054 Chemistry parameter Please delete existing chemistry parameter or rename new chemistry
already exists. parameter.
7070 2 The remaining volume of solution L is
Low solution L inventory. L Solution shortage
not enough. Exchange the pack.
7071 2 ISE cleaning solution is not
ISE cleaning solution is registered. Registration of the solution
Not registered ISE Cleaning
not registered. is required prior to running the ISE
cleaning.
7072 2 ISE cleaning solution-2 is not
ISE cleaning solution-2 is registered. Registration of the solution
Not registered ISE Cleaning2
not registered. is required prior to running the ISE
cleaning.
7073 2 ISE activation sample is not
ISE activation sample is registered. Registration of the sample
Not registered ISE Activation
not registered. is required prior to executing ISE
activation.
7074 2 Remaining volume of solution Ref is
Low solution Ref inventory Ref Solution shortage
not enough. Exchange the pack.
7101 Data of control sample is
near full capacity.
7102 Data of test result is near Save the measurement result or delete unnecessary measurement
full capacity. result.
7103 Data of control sample is
full.
7104 Data of test result is full.
7105 Data of ISE calibrator is
near full capacity.
Save the measurement result or delete unnecessary measurement
7106 Data of ISE calibrator is result.
full.
7107 Data of calibrator sample
is near full capacity.
7108 Data of calibrator sample Save the measurement result or delete unnecessary measurement
is full. result.
7201 Abnormal database size. Return to the installation condition or restore at the back up database.
7202 Auto backup failed.
7203 Database recovery failed. Return to the installation condition or restore at the back up database.
7204 DB damaged. Please
recover data in the Return to the installation condition or restore at the back up database.
database.
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7205 Database returned to
install condition owing to Recover by the backup database depending on the situation.
malfunction.
7206 The memory capacity of
Please delete unnecessary data before saving new data.
data is full.
7207 File of automatic backup
Backup file of the last round was deleted.
is abnormal.
7208 Automatic backup of USB
Please confirm if the USB is available.
was failed.
See also:
■ Sensor List, p.300
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Sensor List
5. Sensor List
The table below gives a list of the Pentra C200 sensors with their abbreviation used in the alarm
messages, their location and function on the instrument.
Sensor Abbreviation Location Function

Probe vertical home PTU_ZERO_POS Probe unit Detects the probe vertical home
position position.
Probe rotation home PTR_ZERO_POS Probe unit Detects the probe rotation home
position position.
Probe trough safety sensor PTR_TS Probe unit Detects that the probe is in one of
the following positions: trough,
DET.W bottle, ISE, STAT.
Probe SRCU position PT_SRCU Probe unit Detects that the probe is in the
Sample and Reagent Container Unit
(SRCU).
Probe down limit sensor PTU_DL Probe unit Detects that the probe has hit on
something (a cap for example).
Probe liquid level sensor PT_EKIMEN Probe unit Detects that the probe has reached
the liquid.
Mixer vertical home position MIXU_ZERO_POS Mixer unit Detects the mixer vertical home
position.
Mixer rotation home MIXR_ZERO_POS Mixer unit Detects the mixer rotation home
position position.
Mixer trough safety sensor MIXR_TS Mixer unit Detects that the mixer is in one of
the following positions: trough,
DET.W bottle.
CLU X-axis home position CLUX_ZERO_POS CLU Detects the Cuvette Loading Unit
(CLU) home position in the X-axis
direction.
CLU Y-axis home position CLUY_ZERO_POS CLU Detects the CLU home position in
the Y-axis direction.
CLU Z-axis home position CLUZ_ZERO_POS CLU Detects the CLU home position in
the Z-axis direction.
Cuvette catch arm home CATCH_POS1 CLU Detects that the cuvette catch arm is
position in its home position.
Cuvette catch arm cuvette CATCH_POS2 CLU Detects that the cuvette catch arm
position holds a cuvette.
Cuvette catch arm down CATCH_LIMIT CLU Detects that the cuvette catch arm
limit sensor has hit on something (a cuvette for
example).
CLU X-axis safety position CLUX_SAFETY CLU Detects the CLU safety position in
the X-axis direction.
CLU Z-axis safety position CLUZ_SAFETY CLU Detects the CLU safety position in
the Z-axis direction.
Cuvette rack sensor (front CR1_POS1 Cuvettes rack Detects the presence or absence of
side) holder unit the front side cuvette rack.
Cuvette rack sensor (back CR2_POS2 Cuvettes rack Detects the presence or absence of
side) holder unit the back side cuvette rack.
Filter wheel home position FLT_ZERO_POS Detector unit Detects the filter wheel home
position.
Lamp fan rotation sensor LAMP_FAN_SEN Detector unit Detects that the lamp fan is stopped.
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Sensor List
Sensor Abbreviation Location Function

IRU rotation home position IRU_ZERO_POS IRU Detects the Incubation Reaction Unit
(IRU) rotation home position.
IRU safety position IRU_READY IRU Detects the IRU safety position.
Dust pod sensor DUST_POS Dust pod Detects the presence or absence of
the dust pod.
SRCU rotation home SRCU_ZERO_POS SRCU Detects the SRCU rotation home
position position.
SRCU cover sensor SRCU_COVER SRCU Detects that the SRCU cover is open
or closed.
SRCU fan 1 rotation sensor SRCU_FAN_SEN1 SRCU Detects that the SRCU fan 1 is
stopped.
SRCU fan 2 rotation sensor SRCU_FAN_SEN2 SRCU Detects that the SRCU fan 2 is
stopped.
Peltier elements power +24V_SRCU_PE_MON SRCU Monitors the power supply of Peltier
supply sensor elements.
Motors power supply +24V_SRCU_MOT_MON SRCU Monitors the power supply of motors.
sensor
Trough chamber overflow OVF_SENS Chassis Detects that the trough chamber
sensor overflows.
Chassis fan rotation sensor CSE_FAN_SEN Chassis Detects that the chassis fan is
stopped.
Main cover sensor CSE_COVER_SEN Chassis Detects that the main cover is open
or closed.
Emergency stop button EMERGENCY_STOP Chassis Monitors the emergency stop button.
sensor
Motors power supply +24V_MAIN_MON Chassis Monitors the power supply of motors.
sensor
Trough leak sensor (probe) LEAK_TR1 Trough Detects that the probe trough leaks.
Trough leak sensor (mixer) LEAK_TR2 Trough Detects that the mixer trough leaks.
DET.W bottle sensor RWS_PT_POS DET.W bottle Detects the presence or absence of
(probe) the probe DET.W bottle.
DET.W bottle sensor (mixer) RWS_MIX_POS DET.W bottle Detects the presence or absence of
the mixer DET.W bottle.
Reagent syringe vertical RPP_UP_ZERO Syringes Detects the reagent syringe vertical
home position home position.
Sample syringe vertical SPP_UP_ZERO Syringes Detects the sample syringe vertical
home position home position.
Wash syringe vertical home WPP_UP_ZERO Syringes Detects the wash syringe vertical
position home position.
STAT unit sensor STAT STAT unit Detects that the STAT unit is open or
closed.
Water tank sensor OUT_BOT_EMP Tank Detects that the water tank is empty.
Waste tank sensor OUT_BOT_FULL Tank Detects that the waste tank is full.
Computer fan rotation CPU_FAN_SEN Computer Detects that the computer fan is
sensor stopped.
Power supply fan rotation PSU_FAN_SEN Power supply unit Detects that the power supply fan is
sensor stopped.
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Error Flags
6. Error Flags
When the instrument meets problems during measurements, the concerned tests are flagged with an
error flag. The table below displays error flags with their description and causes.
Error rank 1
Error Description Error Cause

flag
Not received ISE measurement
IE1 There is no response from ISE for request command.
request
Not received ISE measurement
IE2 The measurement result from ISE could not be received.
result data
The measurement result from ISE could not be printed out due to
IE3 Omission of ISE measurement
the busy state in electrodes.
Error rank 2

flag
The liquid level of PT is not detected or a hit of the bottom is
SS Sample shortage
detected in SRCU.
Non detection of the liquid level of The liquid level of PT is not detected or a hit of the bottom has been
SI1
sample discharge detected in IRU.
When R1 reagent aspirating, the PT liquid level is not detected or a
R1S R1 Reagent shortage
hit of the bottom is detected in SRCU.
When R2 reagent aspirating, the PT liquid level is not detected or a
R2S R2 Reagent shortage
hit of the bottom is detected in SRCU.
When wash solution aspirating, the PT liquid level is not detected or
R1WS R1 Wash solution shortage
a hit of the bottom in DET.W. (At R1 timing).
When wash solution aspirating, the PT liquid level is not detected or
R2WS R2 Wash solution shortage
a hit of the bottom in DET.W. (At R2 timing).
When dilution aspirating, the PT liquid level is not detected or a hit
DS Dilution shortage
of the bottom is detected in SRCU.
When wash solution aspirating, the RPT liquid level is not detected
WS Wash solution shortage
or a hit of the bottom is detected in SRCU.
ABSE Absorbance error The absorbance (in time-course) could not be measured.
R1B No R1 reagent bottle R1 reagent bottle has not been registered.
R1S Volume Zero in R1 reagent The remaining volume of R1 reagent has reached zero.
R2B No R2 reagent bottle R2 reagent bottle has not been registered.
R2S Volume Zero in R2 reagent The remaining volume of R2 reagent has reached zero.
R1 wash solution bottle for method-to-method wash has not been
R1WB No R1 wash solution bottle
registered.
The remaining volume of R1 wash solution for method-to-method
R1WS Volume Zero in R1 wash solution
wash has reached zero.
R2wash solution bottle for method-to-method wash has not been
R2WB No R2 wash solution bottle
registered.
The remaining volume of R2 wash solution for method-to-method
R2WS Volume Zero in R2 wash solution
wash has reached zero.
DB No dilution bottle The dilution bottle has not been registered.
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Error Flags

flag
DS Volume Zero in dilution bottle The remaining volume of the dilution bottle has reached zero.
WB No wash solution bottle Wash solution bottle for PT wash has not been registered.
Volume Zero in wash solution The remaining volume of the wash solution bottle for PT wash has
WS
bottle reached zero.
LOT Lot inconsistency The reagent lot number has not been inconsistency.
PT wash has been failed. Check the alarm to determine the reason
SPW Failure of PT wash (SPT)
for its fail.
Method-to-method washing has failed prior to a R1 operation..
R1W Failure of PT wash (RPT1)
Check the alarm to determine the reason for its fail.
Method-to-method washing has failed, prior to a R2 operation..
R2W Failure of PT wash (RPT2)
Check the alarm to determine the reason for its fail.
DWPB No DET.W bottle for PT DET.W bottle is not placed beside PT unit.
Volume Zero in DET.W solution for
DWPS The remaining volume of DET.W for PT has been zero.
PT
DWMB No DET.W bottle for MIX DET.W bottle is not placed beside MIX unit.
EUT Effective count Zero of DET.W The remaining count of MIX washing by DET.W has been zero.
CS Cuvette shortage Cuvettes in the cuvette rack are insufficient for measurement.
DF Full cuvette in DP DP full up with used cuvettes.
EST Anomalous measurement Error sampling stop. Check the alarm for the reason.
Error rank 3

flag
TE1 IRU temperature extremely low IRU temperature < 37-2(°C).
TE2 IRU temperature extremely high IRU temperature > 37+2(°C).
TE3 RCU temperature extremely high RCU temperature > 15°C.
TE4 RCU temperature extremely low RCU temperature < 2°C.
Error rank 4

flag
EXP The reagent is no longer valid. An expired reagent was used in the measurement.
STB Reagent stability expired Invalid reagent stability was used with the measurement.
The reason is that the measurement was taken by a method of
CTO Calibration expired
which calibration has not been implemented within a setting term.
The reason is that the measurement was taken by a method of
CXP Control expired which QC measurement has not been implemented within a setting
term.
Q Control error Executed the measurement with control error.
An error of concentrations of No calibration curve, or ISE calibration ever has been executed after
CA?
conversions. the startup.
Error rank 5

flag
An error out of the range of
OVR The value is not between Calibrator’s minimum and maximum.
calibrator.
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Error Flags
Error rank 6

flag
LIN Linearity Limit Error Linearity Limit Error.
PRO Prozone Limit Error Prozone Limit Error.
The flag "AB1" is displayed when all measuring points exceed the
AB1 Absorbance Limit1 Error absorbance limit except the first one. No result is displayed (*****) and
a rerun with a post-dilution is performed.
The flag "AB2" is displayed when more than 1 point and less than 5
points are within the absorbance limit. The first result is then
AB2 Absorbance Limit2 Error
calculated with those points and a rerun with post-dilution is
performed.
Error rank 7

flag
Using the different lot number of Used reagent lot number in the specimen or control measurement
CLT
R1 or R2 has been different from the reagent in the calibration measurement.
The measurement was taken by sample type of each method that
does not match the sample type. The concentration value was
STM Sample type Inconsistent
converted with a calibration curve that does not match the sample
type.
Error rank 8

flag
DUP Duplicate Limit Error Duplicate Limit Error.
Error rank 9

flag
SEN Sensitivity Limit Error Sensitivity Limit Error.
CAL Failure of calibration An operation of calibration has filed in shortage of points etc.
Error rank priority is ordered from 1 to 9: 1 > 2 > 3 > 4 > 5 > 6 > 7 > 8 > 9.
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Error Code for ISE
7. Error Code for ISE
When an error occurs during ISE calibration, an error is displayed in the Results of ISE Calibration
screen. The table below displays the error codes with their description.
The error code for ISE module is a four-digit code:
■ 0XXX: electrode errors
■ 1XXX: ISE module errors
Electrode errors
■ The first digit is 0 (zero) for electrode errors.
■ The second digit is the error code for Na electrode.
■ The third digit is the error code for K electrode.
■ The fourth digit is the error code for Cl electrode.
Error code Description

1 2-point calibration: response alert.
2 2-point calibration: stability alert.
3 2-point calibration: reference potential alert.
4 2-point calibration: sensitivity alert.
5 Normal concentration sample: calibration potential alert.
6 Normal concentration sample: sample potential response alert.
7 Normal concentration sample: sample potential response alert + calibration potential alert.
8 High/Low concentration sample: no alert.
9 High/Low concentration sample: reference potential alert.
A High/Low concentration sample: sample potential response alert.
B High/Low concentration sample: sample potential response alert + calibration potential
alert.
Example: 0600 is the electrode error "Normal concentration sample: sample potential response alert."
on the Na electrode.
ISE module errors
Error code Alarm Description

1001 2075 The pumping speed adjustment is beyond the limit.
1021, 1022 2076 Cannot detect Standard I at LB1 sensor.
1023, 1024 2077 Incorrect supplying quantity of Standard I (LB1).
1025 2085 Incorrect supplying quantity of Standard I (LB2).
1026 2084 Cannot detect Standard I at LB2 sensor.
1031, 1032 2078 Cannot detect Standard II at LB1 sensor.
1033, 1034 2079 Incorrect supplying quantity of Standard II (LB1).
1035 2087 Incorrect supplying quantity of Standard II (LB2).
1036 2086 Cannot detect Standard II at LB2 sensor.
1041, 1042 2080 Cannot detect the sample at LB1 sensor.
1043, 1044 2081 Incorrect supplying quantity of the sample.(LB1)
1045 2089 Incorrect supplying quantity of the sample.(LB2)
1046 2088 Cannot detect the sample at LB2 sensor.
User Manual 305

Ref: RAB274BEN
Alarms
Error Code for ISE
Error code Alarm Description

1091 2082 Detects abnormal condition at LB sensor check.
1101 2083 Hardware abnormal.
1996 1975 ISE communication failure.
1997 1978 ISE module is under unmeasurable state.
1998 1984 ISE is working.
1999 1980 - 1983 ISE Unit errors.
See also:
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Ref: RAB274BEN
Description and Technology
1. Instrument Description.....................................................................................................308
1.1. Fluid Storage Module..............................................................................................................308
1.2. Sampling Module....................................................................................................................312
1.3. Analytical Module....................................................................................................................314
2. Measurement Principle.....................................................................................................320
2.1. Absorbance Measurements....................................................................................................320
2.2. Electrolyte Measurements......................................................................................................321
User Manual 307

Ref: RAB274BEN
Instrument Description
1. Instrument Description
The Pentra C200 is designed to measure enzymes, substrates, specific proteins and ions by
colorimetry, turbidimetry and potentiometry.
To allow these measurements the instrument is composed of several modules:
■ Fluid storage module
■ Sampling module
■ Analytical module
1.1. Fluid Storage Module
1.1.1. Reagent
Reagents are packaged in cassettes. Cassettes are kept on the reagent tray in the Sample and
Reagent Container Unit (SRCU). The SRCU is refrigerated between 8°C and 15°C by Peltier elements.
Reagent and sample trays must be removed from the SRCU to load reagent cassettes. The sample
tray need to be detached by pulling it up to access the reagent tray slots.
Reagent and sample tray removal from the SRCU Sample and reagent tray dismantling
Only cassettes can be used in the reagent tray. The reagent tray has 15 numbered positions and
reagent cassettes can be placed in any available position.
Ideally cassettes should be placed in the tray in positions which balance the tray.
Reagents are available in single or twin compartment cassettes. Reagents provided in vials must be
transferred in open cassettes and identified with barcode stickers (Stickers for reagent cassettes on
Pentra C200 HAX0297B) provided by HORIBA Medical.
308 User Manual

Ref: RAB274BEN
Barcode sticker location
1 = Sticker location
2 = 11.5 mm
Reagent and sample trays are replaced in the SRCU by inserting the two guide pins in the two bigger
holes of the reagent tray. The correct positioning of the trays is insured by pressing on the center of
the trays.
The caps must be removed from the cassettes and if necessary, bubbles can be removed with a
Pasteur pipette.
The SRCU is equipped with a barcode reader which allows the reading of cassette barcodes. For
cassette inventory, a barcode scan must be performed by using the Barcode Scan button in
Inventory > Reagent Tray (tab) . The reading of the barcode leads to the automatic recording of the
solution characteristics.

moved or removed.
A color code is displayed for each cassette to allow checking the reagent status. Press the blue
background outside reagent tray representation on the main screen to display the color legend.
Warning! Reagents, diluents and cleaners should be handled cautiously according to their
corresponding notice.
User Manual 309

Ref: RAB274BEN
See also:
1.1.2. Sample
Samples are located in the sample tray which is kept in the Sample and Reagent Container Unit
(SRCU). The SRCU is refrigerated between 8°C and 15°C by Peltier elements.
Barcode specifications
Type Data digit number Check digit Effective characters

CODE39 From 3 to 11 digits 1 digit, Modulus 43 Numbers (from 0 to 9)
Alphabets (capital letters)
Symbols (-, $, :, /, ., +, %, space)
Codabar (NW-7) From 3 to 12 digits 1 digit, Modulus 16 Numbers (from 0 to 9)
Symbols (-, $, :, /, ., +)
ITF2/5 From 3 to 12 digits 1 digit, Modulus 10 Numbers (from 0 to 9)
CODE128 (Set A, B) From 3 to 12 digits Modulus 103 Numbers (from 0 to 9)
Alphabets (capital and small letters)
CODE128 (Set C) From 3 to 12 digits 2 digits, Modulus 103 Numbers (from 0 to 9)
1 = Barcode location (65 mm)
2 = 8 mm for tubes in SRCU, 12.6 mm for tubes in STAT position
■ Barcode module width: 0.25 mm or more

■ Barcode height: 15 mm or higher
■ Barcode length: 65 mm or shorter, including quiet zone
■ Quiet zone: 2.54 mm or 10 times the length of the minimum module width, whichever the greater
■ Printing: Black on white background. Quality standard must comply with the ANSI MH10.8M
standard.
Samples can be placed in the sample tray without removing the tray from the SRCU. The sample tray
has 15 numbered positions and sample tubes can be placed in any available position.
Sample tubes are held in position in the sample tray by a tube holder. Tubes with a diameter from 13
mm to 16 mm and with a length from 75 mm to 100 mm are compatible with the sample holders.
Sample cups are accepted with the use of an adapter. To use a sample cup, place the adapter in the
sample tray, remove the cap from the sample cup (cut) and place the sample cup at the top of the
adapter.
310 User Manual

Ref: RAB274BEN
■ Do not wash or re-use sample tubes or cups. They are designed for single use only.
■ When filling sample tubes or sample cups, dispense the sample slowly in order to
avoid the formation of foam.
■ Sample tubes or cups must always be uncapped before being positioned on the
sample tray.
Dispose of used sample tubes or cups according to your local/national guidelines for
Emergency sample
Emergency samples (STAT sample) can be introduced at any time during measurement at a dedicated
position on the left side of the instrument (STAT). The STAT unit provides one tube holder for tube or
sample cup (with adapter).
For the STAT position, sample height within the tube must be higher than 12.6 mm.
The STAT unit is opened and closed by pushing slightly on the STAT cover.
During analysis the STAT unit is locked. The STAT button from the generic toolbar allows to unlock
the STAT unit.
The STAT position is not equipped with a barcode reader.
User Manual 311

Ref: RAB274BEN
See also:
■ STAT Sample Status, p.48
■ To Run Emergency Sample, p.115
1.1.3. Cleaning Solution
Several cleaning solutions can be used during measurements and maintenance procedures. Three
locations are used for cleaning solutions:
■ External tank for water.
■ Cassettes on the reagent tray for maintenance procedures and special probe wash during
measurements.
■ Two DET. W bottles for probe and mixer cleaning procedures during measurements.
1 = DET.W bottle for mixer
2 = DET.W bottle for probe
DET.W bottles are dedicated containers with a 20 mL capacity for mixer paddle and probe cleaning.
Volume of the probe's DET.W bottle decrease after each wash. The remaining volume can be checked
by pressing DET.W Volume Check in Services > Customer Services > Sequence (tab) . Volume is
displayed in mL in the window next to the volume check button.
The mixer's DET.W bottle volume remain unchanged during use. The solutions needs to be changed
weekly.
1.2. Sampling Module
Sample, reagent and wash solutions are aspirated and dispensed by dedicated syringe pumps and a
common probe.
312 User Manual

Ref: RAB274BEN
1.2.1. Syringe Pumps
Three syringes are located behind the vertical cover on the left of the front panel. Each syringe
assembly includes a glass barrel and a metal plunger fitted with a Teflon tip. Syringes are operated by
the coordinated action of a motor (behind) and a valve (top of the syringe).
1 = Wash pump unit (WPP)
2 = Reagent pump unit (RPP)
3 = Sample pump unit (SPP)
The three syringes are dedicated to:

■ WPP: the wash pump unit is used for the probe cleaning with distilled water. It allows volume up
to 2 mL.
■ RPP: the reagent pump unit is used for reagent and distilled water aspiration and dispensing. It
allows volume from 20 µL to 350 µL with a 1 µL increment.
■ SPP: the sample pump unit is used for sample and distilled water aspiration and dispensing. It
allows volume from 2 µL to 45 µL with a 0.1 µL increment.
1.2.2. Probe
The probe is common for reagent and sample dispensing. The outside of the probe is briefly cleaned
by water from the wash tower after each aspiration. Additional cleaning with Clean-Chem could be
programmed to prevent carry over.
User Manual 313

Ref: RAB274BEN
The probe is equipped with shock detection, level detection and foam detection.
Before each aspiration of reagent or sample an air gap is introduced to separate the solution from the
water. Before each aspiration of reagent or sample, an extra volume of reagent or sample is aspirated.
Sample:
Sample aspiration:
1 = water
2 = 12 µL air
3 = 7 µL sample (extra volume)
4 = X µL sample
Reagent:
Reagent aspiration:
1 = water
2 = 12 µL air
3 = 15 µL reagent (extra volume)
4 = X µL reagent
1.3. Analytical Module
The Pentra C200 allows colorimetic, turbidimetric and potentiometric (optional) measurements.
Colorimetric and turbidimetric measurements require the reaction of samples with one or two
reagents. The reaction takes place in cuvettes in an incubation unit at 37°C and a spectrophotometer
is used for the quantification of the reaction. Such measurements require the use of cuvettes, cuvettes
loading unit, incubation reaction unit, mixer unit, spectrophotometer and dust pod.
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Ref: RAB274BEN
Potentiometric measurements (optional) require the contact of samples with an ion selective electrode
(ISE) and a reference electrode. The electrical potential difference measured allows the quantitation of
the specified ion. Such measurements require the use of reference solution, reference electrode, ion
selective electrode and an ISE module.
1.3.1. Cuvettes Management
Cuvettes are managed by the Cuvette Loading Unit (CLU). The CLU allows the transfer of cuvettes
from the cuvette rack to the Incubation Reaction Unit (IRU) and after measurement completion, the
disposal of the cuvettes from the IRU to the dust pod.
1 = Cuvette Loading Unit (CLU)
2 = Cuvette racks
3 = Incubation Reaction Unit (IRU)
4 = Dust Pod (DP)
Cuvettes
Cuvettes used on the Pentra C200 are disposable resin cuvettes with a 6 mm lightpath. The new
cuvettes are stored in the cuvette rack mount unit above the IRU.
The cuvette rack mount unit can hold two racks of 96 cuvettes. A Remaining Cuvettes screen is
available to check the number of available cuvettes for measurements (press Cuvette button from the
main screen).
■ Care should be taken in the storage and handling of the cuvettes in order to prevent
breakage, damage or contamination.
■ Cuvette racks should be left in the plastic wrapping until use to prevent dust
contamination.
■ Cuvettes should be handled only by the upper part.
■ Do not wash and re-use cuvette. They are designed for single use only.
Dispose of used cuvette segments according to your local/national guidelines for

CLU mechanisms
The CLU consists of two parts:
User Manual 315

Ref: RAB274BEN
■ The locomotion mechanism: three motors to move the CLU back and front, right and left, up and
down.
■ The cuvette catch arm.
CLU coordination
When running ordered measurements, the CLU brings a new cuvette from the cuvette rack to the IRU
before the first reagent dispensing. After completion of the kinetic measurement, the CLU discards
the used cuvette from the IRU into the dust pod.
The user is not allowed to handle manually cuvettes in the IRU.
Dust pod
The dust pod can accomodate up to 216 used cuvettes in a disposable dust bag. Current amount of
acceptable used cuvettes in the dust pod is displayed by the Remaining Cuvettes screen (press
Cuvette button from the main screen).
See also:
■ To Check Cuvettes, p.79
■ To Check Dust Pod, p.80
1.3.2. Incubation Reaction Unit
Reaction for colorimetric or turbidimetric measurements takes place in an Incubation Reaction Unit
(IRU) which temperature is regulated at 37 ± 0.3°C by two silicon-rubber heaters. The IRU's
temperature is monitored at two locations and is displayed as graph or numeric values in the
Performance tab in Services > Customer Services .
If during measurement IRU's temperatures are lower or higher than the normal temperature range, the
instrument proceeds to measure and an alarm (6520/6521) is triggered to specify that the temperature
was not accurate during measurement procedure.
If IRU's temperatures are lower than 35°C or higher than 39°C an alarm (3051/3052) is triggered to
warn you that a mechanical problem has occured.
The IRU can accomodates 24 cuvettes and turns in a counterclockwise direction to reach the
following positions:
■ Cuvette loading position for new cuvette in the IRU,
■ Probe position for sample and reagent dispensing,
■ Stirring position for mixing of the solutions by the mixer paddle,
■ Light beam position for light absorption measurement by the spectrophotometer,
■ Cuvette disposal position that allows the cuvette loading unit to discard the used cuvettes into the
dust pod.
See also:
■ Performance, p.247
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Ref: RAB274BEN
1.3.3. Mixer Unit
The mixer unit is used to homogenize solutions in the cuvettes. It stirs the mixture after dispensing of
reagent 1 + sample and after reagent 2 dispensing (if reagent 2 is used in the application).
The mixing speed varies according to the application.
The mixer paddle is cleaned after each use with distilled water in its wash tower or with a wash
solution in its DET.W bottle if specified in the application.
1.3.4. Spectrophotometer
The reaction analysis is followed by a detection unit (DTR) which measures the light absorption with a
spectrophotometer. A filter wheel allows you to choose one or two wavelengths among eight
wavelengths (340, 405, 510, 546, 570, 600, 660, 700 nm). During the reaction process, measurements
are performed every 20 seconds.
1 = Halogen lamp
2 = Condensing lens
3 = Filters wheel
4 = Cuvette
5 = Photodiode
The minimal volume required for accurate measurement is 120 µL.
1.3.5. ISE Module (optional)
The ISE module is located on the left-hand side of the instrument.
User Manual 317

Ref: RAB274BEN
1 = ISE module
2 = STAT
The ISE module is designed to determine sodium, potassium and chloride concentrations in serum,
plasma or urine samples. It uses three Ion Selective Electrodes (ISE) for the measurement of each ion
concentration and one reference electrode.
■ The sodium electrode consists of a glass membrane selective to Na+ ions.
■ The potassium electrode consists of a PVC crown ether membrane which is selective to K+ ions.
■ The chloride electrode is a plastic membrane electrode selective to Cl- ions.
■ The reference electrode consists of an open liquid junction.
The four electrodes are compact and located in a Faraday cage to minimize the influence of
electromagnetic fields. The electrodes are supplied ready to use and no assembly is required.
In order to minimize environment interferences, the ISE module cover must always be
closed during the ISE module operation.
Sodium, potassium and chloride are measured on:

■ undiluted serum and plasma samples
■ diluted urine samples
For serum and plasma samples, 93 µL of sample are pipetted by the probe and 52 µL are dispensed
into the ISE module sample cup. For urine samples, 27 µL of sample are pipetted by the probe and 20
µL are dispensed and diluted with 120 µL of Standard 1 into a cuvette. 52 µL of that dilution are
dispensed into the ISE module sample cup.
The sample flows through the air sensor to reach the ISE block. The air detection by air sensor
indicates the end of sample transfer from the sample cup to the ISE block. The reference solution
flows through the reference electrode and merges with the sample downstream of the ISE block.
The electrical potential is measured between each ion selective electrode and the reference electrode.
This measured potential is a function of the ion concentration.

Chloride 28 - 53 5.0 - 9.4
Potassium 37 - 67 9.0 - 16.3
Sodium 38 - 65 8.5 - 14.4
ISE module consumables

The following table lists the references of the ISE module consumables:
318 User Manual

Ref: RAB274BEN
Reference Designation
A11A01717 ABX Pentra Standard 1
A11A01718 ABX Pentra Standard 2
A11A01719 ABX Pentra Reference
A11A01769 ABX Pentra Etching CP
A11A01738 ABX Pentra Sodium-E
A11A01739 ABX Pentra Chloride-E
A11A01740 ABX Pentra Potassium-E
A11A01741 ABX Pentra Reference-E
A11A01851 ABX Pentra Dummy Electrode
XEA935AS Cleaning kit for ABX Pentra Chloride-E
The ISE prime, the ISE cleaning and the ISE calibration can be executed after their order in the
worklist under Sequence screen ( Main menu > Services > Customer Services > Sequence (tab) ).
An ISE activation must always be performed after ISE cleaning or electrode exchange.
See also:
■ Sequence, p.244
User Manual 319

Ref: RAB274BEN
Measurement Principle
2. Measurement Principle
2.1. Absorbance Measurements
When a light beam travel through a solution its intensity is reduced. The decrease in light intensity is
linked to the wavelength, the path length and the characteristics of the solution at this wavelength
(sample concentration and molar absorption).
1 = Air
2 = Sample
The aborbance at a specific wavelength (A λ ) of a solution can be deduced from the light intensity
measurement (I):
A λ = - log (I / I0)
In the Pentra C200, I0 is the light intensity through air. I0 is measured without cuvette before each
cuvette loading.
The absorbance is proportional to the concentration:
Aλ = ελ . l . c
Where ε is the molar absorption, l is the path length and c is the concentration.
To avoid effects of some cuvette defects, lamp intensity variations and sample interferences, a
second wavelength can be used as a reference:
AMeas = A λ1 - A λ2
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Ref: RAB274BEN
2.2. Electrolyte Measurements
Principle
The measurement principle of the ISE module is based on the interaction between moveable free ions
in a sample solution and an active sensing unit (ion selective sensing electrode).
An ion-selective membrane seperates the sample solution, where the electrolyte concentration is
unknown, from the electrode electrolyte, where the concentration is known.
1 = Reference electrode.
2 = Selective electrode (for the ion measured).
3 = Electrolyte (known concentration).
4 = Voltage measurement.
5 = Selective membrane.
In order to measure this potential change, a reference electrode with a fixed potential is immersed in
the same solution. The potential of the reference electrode is kept fixed and constant, by filling it with
an electrolyte that has a constant concentration.
The electrical potential is measured between each ion selective electrode and the reference electrode.
This measured potential is function of the ion concentration.
The potential of an ion selective electrode depends on the logarithm of the activity of this ion. This
relationship is described by the Nernst equation:
E = E0 + S . log ai
Where:
■ E is the measured potential between ion selective electrode and reference electrode.
■ E0 is the standard potential of electrode assembly.
■ S is the electrode slope (Nernst factor).
■ ai is the activity of measured ion.
S = (2.303 . R . T) / (n . F)
Where:
■ 2.303 is the conversion factor for ln to log.
■ R is the gas constant.
■ T is the absolute temperature (°K).
■ n is the valency of the ion.
■ F is the Faraday's constant.
If the ionic strength of the calibrating solution is equal to that of the sample, the electrode system can
be calibrated with accuracy using concentration instead of activity.
E = E0 + S . log C
Where C is the concentration of the measured ion.
Relative measurements are performed to eliminate temperature influence.
User Manual 321

Ref: RAB274BEN
Calibration
The slope of the measuring system is defined as being the variation in voltage obtained when the ion
concentration is multiplied by 10. It is determined by measuring two different standard solutions.
Taking into account the logarithm relationship between concentration and voltage in the Nernst
equation, the slope is calculated as follows.
S = (ESTD-1 - ESTD-2) / log (CSTD-1 / CSTD-2)
Where:
■ S is the slope.
■ ESTD-1,2 is the measured potential of Standard 1 or 2.
■ CSTD-1,2 is the known concentration of Standard 1 or 2.
Results
The unknown concentration is calculated by comparing the measured potential with the potential of
standard solution which has a known concentration.
C = CSTD-1 . 10^[(E - ESTD-1) / S]
Where:
■ C is the unknown concentration of control or sample.
■ CSTD-1 is the known concentration of Standard 1.
■ E is the measured potential of control or sample.
■ ESTD-1 is the measured potential of Standard 1.
■ S is the slope.
322 User Manual

Ref: RAB274BEN
Index
A Alarm, 254
Absorbance Limit, 172 Barcode, 89, 308
Alarm, 274 Cassettes Loading, 86
Sensor, 300 Deletion, 93
Application Configuration, 159 Detection Problem, 253
Application Management, 164 Inventory, 82, 83, 85
Application Open Cassettes, 94, 308
Absorbance Limit, 169 Registration, 89, 90, 93
Application Codes, 193 Status Problem, 254
Blank Measurement, 173 Changing Operator, 77
Copy, 164 Cleaning
Correlation Factor, 176 Covers Cleaning, 226
Delete, 167 Daily Cleaning, 199, 206, 227
Duplicate Limit, 169 Decontamination, 228
Export, 167 Disinfectant Product, 196
Import, 167 External Tanks Cleaning, 211
Incompatibility, 182, 183 Frequency, 196
Limit Checks, 169 ISE, 126, 198, 202, 205
Linearity Limit, 169 Probe Cleaning, 209, 227
Profile, 180 SRCU Cleaning, 199, 206
Prozone Limit, 169 Tools, 196
Sensitivity Limit, 169 Tubing Cleaning, 211
Audible Alarm, 41, 138 Weekly Cleaning, 209
Auto Backup, 141 Comment Registration, 149
Computer, 32
B Control
Background Noise, 18 Check, 103
Backup, 141 Lot Number, 193
Auto Backup, 141 MSDS, 33
Database Backup, 240 Notice, 33
Database Management, 241 Order, 101
Parameters Backup, 239 Problems, 263
Barcode Scan, 89 Registration, 190, 191
Blank Measurement, 173 Results, 104
Target Value, 191, 193
C Validity, 100
Calibration Copyright, 8
Check, 103 Correlation Factor, 176
Configuration, 185 Counter, 248
Multi Standard, 189 Covers
Order, 100 Covers Cleaning, 226
Problem, 261 Cuvettes
Results, 104 Cuvette Management, 79, 315
Serial Dilution, 187 Cuvettes Loading Unit, 315
Validity, 100 Dust Bag Replacement, 225
Calibrator Used Cuvettes, 80, 315
MSDS, 33
Multi Standard, 189 D
Notice, 33 Database
Cassettes Auto Backup, 141
User Manual 323

Ref: RAB274BEN
Database Backup, 240 Host Connection, 145
Database Management, 241 Humidity conditions, 18, 31
Date, 138
Declaration of Conformity, 7 I
Decontamination, 228 Incubation Reaction Unit
Deproteinizer, 128, 200, 211 Capacity, 316
DET.W Bottle, 312 Temperature, 247, 257
Auto Dilution, 244 Temperature Management, 316
DET.W Changing, 207 Installation, 19
Registration, 83, 90, 155 Instrument Status, 41
Detector Unit, 317 Interferences, 36
Performance, 247 Inventory, 82, 83
Dimensions, 31 ISE
Disposal Activation, 127, 199
Accessories, 19 Chloride Electrode, 317
Consumables, 19 Cleaning, 126, 198, 202, 205
Instrument, 19 Electrode Replacement, 222
Duplicate Limit, 169 Error Code, 305
Dust Pod, 80, 315 Etching, 126, 198, 202, 205
Bag Replacement, 225 ISE Calibration, 97, 98
ISE Calibration Problems, 267
E ISE Consumables, 317
Electrical Problem, 274 ISE Control Problems, 269
Electrode ISE Solutions Management, 201
Chloride Electrode, 317 Parameters Configuration, 177
Potassium Electrode, 317 Potassium Electrode, 317
Reference Electrode, 317 Principle, 321
Replacement, 222 Reference Electrode, 317
Sodium Electrode, 317 Sodium Electrode, 317
Electromagnetic Environment Check, 18
Electronic and Moving Parts, 11 K
Emergency Stop, 274 Keyboard, 41, 50
Emergency
Emergency Sample Status, 48 L
Run, 115 Label
Sample Registration, 115 Serial number, 21
Environment, 17 Warnings, Cautions, 23
Environmental Protection, 19 Lamp
Error, 274 Lamp Replacement, 230
Flag, 302 Work Hours, 230
ISE, 305 Linearity Limit, 170
Etching, 126, 198, 202, 205 LIS Connection, 145
European Legislation, 33 Location Registration, 148
Log File, 242
F Login, 77
Flags, 302 Logos
Flags Rules, 191 Definition, 7
Logout, 77
G
Generic Toolbar, 41 M
Grounding, 18 Maintenance
Covers Cleaning, 226
H Disinfectant Product, 196
Help, 41 External Tanks Cleaning, 211
324 User Manual

Ref: RAB274BEN
Frequency, 196 Printer, 25
Lamp Replacement, 230 Printer operation problems, 253
Operations, 244 Probe
Probe Cleaning, 209, 227 Aspiration/Dispensing Cycle, 313
Probe Replacement, 219 Probe Cleaning, 128, 200, 209, 211,
SRCU Cleaning, 199, 206 227, 244, 312
Syringe Plunger Tip Replacement, 215 Probe Replacement, 219
System Limitations, 36 Profile, 180
Tools, 196 Prozone Limit, 171
Tubing Cleaning, 211
Mask, 181 Q
Measurement Quality Control
Start, 102, 114 Cumulative Statistics, 68, 70
Timing, 48 Daily Statistics, 64, 66
Mechanical Problem, 274 Detailed Control Results, 60
Menu Details, 60, 62
Access Buttons, 42 Graph, 57, 58
Main Menu Description, 42
Method R
Available On Board, 85 Race Registration, 149
Configuration, 159 Range
Method Codes, 193 Age Range, 153
Method to Method Calculation, 178 Patient Range, 152
Mixer Reagent Aspiration/Dispensing, 313
Mixer Cleaning, 312, 317 Reagent Cassettes, 308
Mixer Cycle, 317 Reagent Pump (RPP), 313
MSDS, 41 Reagent Tray, 43, 86, 308
Multi Standard, 189 Reagent
Cassettes Barcode, 308
N Delete, 158
Notice of Liability, 7 Identification, 29
Inventory, 82, 83, 85
O MSDS, 33
Open Cassette Notice, 33
Open Cassette Barcode, 308 On Board, 85
Open Cassette Registration, 94 On board capacity, 29
Order, 110 On board temperature, 29
Open Cassettes, 308
P Packaging, 28, 308
Package Content, 19 Performance, 34
Patient Registration, 155
Information, 151 Volume, 29
Registration, 150 Reagents
Results, 117 Notices, 33
Results Problems, 265 Recommendations, 33
Physician Registration, 147 Results
Pictograms Archives, 120
Definition, 7 Display, 117, 118
Power Output, 120
Problem, 252 Print Reports, 118, 139
Requirements, 31 Problems, 259, 260, 261, 263, 265
Supply, 18, 31 Raw Data, 120
Precautions, 10 Search, 120
Precision Test, 214 Run Results
User Manual 325

Ref: RAB274BEN
Calibration, 103, 104 Nota, 7
Control, 103, 104 Target, 7
Patient, 117 Syringe Pumps
Plunger Tip Replacement, 215
S Reagent Pump, 313
Sample and Reagent Container Unit Sample Pump, 313
Reagent Tray, 308 Wash Pump, 313
Sample Tray, 310
SRCU Cleaning, 199, 206 T
Temperature, 247, 257 Tanks
Sample Aspiration/Dispensing, 313 Alarms, 256
Sample Pump (SPP), 313 External Tanks Cleaning, 211
Sample Tray, 44, 310 Waste Tank Management, 127
Sample Water Tank Management, 127
Barcode, 144, 310 Temperature conditions, 18, 31
Dilution, 29 Throughput, 28
Identification, 29 Time, 138
Identification Problem, 255 Trademarks, 8
On board capacity, 29 Transportation, 19
On board temperature, 29 Tubing
Order, 106, 110 Tubing Cleaning, 211
Registration, 110
Sample cups, 310 U
STAT (Emergency Sample), 115, 310 User
Tube, 29, 310 Change, 77
Type, 29, 76 Delete User, 136
Volume, 29, 76 Login, 77
Screen Register User, 135
Calibration, 244 User Management, 134
Sensitivity Limit, 170 User Status, 48
Sensor, 300 User's Level, 137
Serial Dilution, 187 User's Password, 136
Serial number label, 21
Settings, 143 W
Shutdown, 41 Warranty, 10
Extended Shutdown with ISE, 233 Wash Pump (WPP), 313
Extended Shutdown without ISE, 234 Waste
Sleep Handling precautions, 34
Automatic Wake Up, 77 Water
Enter Sleep, 130 Conductivity, 32
Manual Wake Up, 131 Requirement, 32
Settings, 129, 142, 249 Resistivity, 32
Software Wavelength, 317
Problem, 274 Weight, 31
Version, 250 Work Hours Counters, 248
Sound level, 31 Workflow, 0
Spectrophotometer, 317 Worklist, 110
Performance, 247
Principle, 320
Start, 102, 114
Storage Conditions, 19
Symbols definition
Caution, 7
Danger, 7
326 User Manual

Ref: RAB274BEN

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Clinical Chemistry Analyzer

4. Labels and Connections.....................................................................................................21

2. Graph from Control Results..............................................................................................57

4. Reagent Cassette Management.....................................................................................82

5. Calibration and Control......................................................................................................97

3. Patient and Sample Information Configuration......................................................147

Maintenance and Troubleshooting..........................................................................195

3. Alarm Code Principle.........................................................................................................277

7. Error Code for ISE...............................................................................................................305

Description and Technology.........................................................................................307

User Manual iii

Index Reference Software Version Date

2.1. Declaration of Conformity

2.2. Notice of Liability

2.3. Document Symbols

Gives a summary of what can be achieved if the task is performed.

Microsoft and Windows are registered trademarks of Microsoft Corporation.

2.6. Copyright ® 2010 by HORIBA ABX SAS

HORIBA ABX SAS

1. Warning and Precautions..................................................................................................10

4. Labels and Connections.....................................................................................................21

1. Warning and Precautions

1.1. Limited Warranty

1.2. Safety Precautions

1.2.1. Electronic and Moving Parts

The following parts must not be handled or checked by the user:

1.2.2. Biological Risk

All accessible surfaces of the instrument can be potentially contaminated by human

1.3. Graphics and Symbols

Switch off position Switch on position

Alternating current Manufacturer

In Vitro Diagnostic medical This product conforms to the EC Directives

Fragile, handle with care Handle with care

Do not stack Keep dry

Batch code Catalogue number

Use by Install before

Content Single use only

This product should be disposed of and

Risk of injury Risk of electric shock

The Pentra C200 includes several units:

1 = Sample and Reagent Container Unit (SRCU)

2 = Cuvettes rack holder unit (CM)

3 = Incubation Reaction Unit (IRU)

4 = Dust Pod unit (DP)

5 = Cuvette Loading Unit (CLU)

6 = Probe unit (PT)

7 = Probe wash tower

9 = Mixer unit (MIX)

10 = Mixer wash tower

11 = Ion Selective Electrodes module (ISE)

12 = ISE solution compartment

3 = Emergency stop button

■ Place your instrument on a clean and leveled table or workbench.

■ Avoid exposure to sunlight.

3.4. Humidity and Temperature Conditions

3.5. Electromagnetic Environment Check

3.6. Main Power Supply

3.7. Environmental Protection

Used Accessories and Consumables Disposal

If any doubt, please contact your local representative.

3.8. Storage Conditions and Transportation

Instrument storage temperatures: from -10°C (+14°F) to +50°C (+122°F).

Prior to the shipping of an instrument by transporter, whatever the destination, an